Trial Outcomes & Findings for Micronutrients for Attention-Deficit Hyperactivity Disorder in Youth (MADDY) Study (NCT NCT03252522)
NCT ID: NCT03252522
Last Updated: 2023-02-08
Results Overview
Primary outcome measure, defined a priori, reflecting the often-comorbid ADHD symptoms of emotional dysregulation irritable mood, anger or aggression), are the parent-rated Child and Adolescent Symptom Inventory (CASI-5). The CASI-5 is based on the DSM-5 symptom criteria. The subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict that will be combined into a total composite score; range is 0-3 (never, sometimes, often, very often). Higher scores represent a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
135 participants
Primary outcome timeframe
Baseline and week 8
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Intervention
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Open Label
All participants have the option to participate in an 8-week, naturalistic, open label follow-up in which the child will take the active micronutrient treatment; capsules of broad spectrum micronutrients.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
|---|---|---|---|
|
Phase 1: Intervention & Placebo
STARTED
|
78
|
57
|
0
|
|
Phase 1: Intervention & Placebo
COMPLETED
|
69
|
54
|
0
|
|
Phase 1: Intervention & Placebo
NOT COMPLETED
|
9
|
3
|
0
|
|
Phase 2: Open Label
STARTED
|
0
|
0
|
123
|
|
Phase 2: Open Label
COMPLETED
|
0
|
0
|
99
|
|
Phase 2: Open Label
NOT COMPLETED
|
0
|
0
|
24
|
Reasons for withdrawal
| Measure |
Intervention
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Open Label
All participants have the option to participate in an 8-week, naturalistic, open label follow-up in which the child will take the active micronutrient treatment; capsules of broad spectrum micronutrients.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
|---|---|---|---|
|
Phase 1: Intervention & Placebo
Adverse Event
|
3
|
1
|
0
|
|
Phase 1: Intervention & Placebo
Unable to swallow pills
|
4
|
1
|
0
|
|
Phase 1: Intervention & Placebo
Commenced stimulant medication
|
1
|
1
|
0
|
|
Phase 1: Intervention & Placebo
Protocol Violation
|
1
|
0
|
0
|
|
Phase 2: Open Label
Commenced stimulant medication
|
0
|
0
|
3
|
|
Phase 2: Open Label
Lack of Efficacy
|
0
|
0
|
3
|
|
Phase 2: Open Label
Adverse Event
|
0
|
0
|
2
|
|
Phase 2: Open Label
Lost to Follow-up
|
0
|
0
|
16
|
Baseline Characteristics
Participants included in the ITT analysis.
Baseline characteristics by cohort
| Measure |
Intervention
n=78 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=57 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
78 Participants
n=78 Participants
|
57 Participants
n=57 Participants
|
135 Participants
n=135 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=78 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=135 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=78 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=135 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=78 Participants
|
22 Participants
n=57 Participants
|
43 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=78 Participants
|
35 Participants
n=57 Participants
|
92 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
45 Participants
n=78 Participants
|
40 Participants
n=57 Participants
|
85 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
7 Participants
n=78 Participants
|
1 Participants
n=57 Participants
|
8 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
4 Participants
n=78 Participants
|
3 Participants
n=57 Participants
|
7 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown/Did Not Report
|
22 Participants
n=78 Participants
|
13 Participants
n=57 Participants
|
35 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=78 Participants
|
0 Participants
n=57 Participants
|
3 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Race · African American/Black
|
1 Participants
n=78 Participants
|
3 Participants
n=57 Participants
|
4 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
60 Participants
n=78 Participants
|
45 Participants
n=57 Participants
|
105 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=78 Participants
|
4 Participants
n=57 Participants
|
7 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/Not Reported
|
11 Participants
n=78 Participants
|
5 Participants
n=57 Participants
|
16 Participants
n=135 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=71 Participants • Participants included in the ITT analysis.
|
17 participants
n=55 Participants • Participants included in the ITT analysis.
|
38 participants
n=126 Participants • Participants included in the ITT analysis.
|
|
Region of Enrollment
United States
|
50 participants
n=71 Participants • Participants included in the ITT analysis.
|
38 participants
n=55 Participants • Participants included in the ITT analysis.
|
88 participants
n=126 Participants • Participants included in the ITT analysis.
|
PRIMARY outcome
Timeframe: Baseline and week 8Primary outcome measure, defined a priori, reflecting the often-comorbid ADHD symptoms of emotional dysregulation irritable mood, anger or aggression), are the parent-rated Child and Adolescent Symptom Inventory (CASI-5). The CASI-5 is based on the DSM-5 symptom criteria. The subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict that will be combined into a total composite score; range is 0-3 (never, sometimes, often, very often). Higher scores represent a worse outcome.
Outcome measures
| Measure |
Intervention
n=78 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=57 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
CASI-5 Parent-rated Composite Score
Baseline
|
1.49 score on a scale
Standard Error 0.08
|
1.52 score on a scale
Standard Error 0.08
|
—
|
—
|
|
CASI-5 Parent-rated Composite Score
Week 8
|
1.18 score on a scale
Standard Error 0.08
|
1.23 score on a scale
Standard Error 0.08
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 8Population: Participants considered in the ITT analysis
Second primary measure is the blinded clinician-rated CGI-Improvement (CGI-I) is a subscale of the CGI that rates overall improvement of symptoms based on all relevant data. Item range is 1-7 (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse); lower score is better. A treatment responder is defined as a participant who is rated a 1 or 2 on the CGI-I. The CGI-Severity (CGI-S) subscale will also be scored at baseline and week 8, with scores compared at the two time points. Item range is 1-7 (normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients); lower score is better; most participants will be a 4 or 5 at baseline.
Outcome measures
| Measure |
Intervention
n=71 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=55 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
Clinical Global Impression (CGI) - Number of Participants Considered a Treatment Responder (Score of 1 or 2)
|
38 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Outcome measures
| Measure |
Intervention
n=50 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=50 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L
Sodium
|
139.13 mmol/L
Standard Error 0.34
|
139.16 mmol/L
Standard Error 0.34
|
139.28 mmol/L
Standard Error 0.36
|
139.42 mmol/L
Standard Error 0.37
|
|
Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L
Potassium
|
4.1 mmol/L
Standard Error 0.10
|
4.06 mmol/L
Standard Error 0.10
|
4.09 mmol/L
Standard Error 0.10
|
4.0 mmol/L
Standard Error 0.10
|
|
Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L
Chloride
|
105.07 mmol/L
Standard Error 0.96
|
104.81 mmol/L
Standard Error 0.97
|
104.88 mmol/L
Standard Error 0.97
|
105.28 mmol/L
Standard Error 0.98
|
|
Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L
Carbon dioxide
|
25.62 mmol/L
Standard Error 0.21
|
25.64 mmol/L
Standard Error 0.22
|
25.97 mmol/L
Standard Error 0.24
|
25.86 mmol/L
Standard Error 0.25
|
|
Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L
Anion gap
|
10.30 mmol/L
Standard Error 2.83
|
10.64 mmol/L
Standard Error 2.83
|
10.31 mmol/L
Standard Error 2.83
|
10.15 mmol/L
Standard Error 2.84
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Outcome measures
| Measure |
Intervention
n=50 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=50 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL
Calcium
|
9.47 mg/dL
Standard Error 0.20
|
9.49 mg/dL
Standard Error 0.20
|
9.47 mg/dL
Standard Error 0.20
|
9.40 mg/dL
Standard Error 0.20
|
|
Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL
Blood urea nitrogen (BUN)
|
12.48 mg/dL
Standard Error 0.41
|
13.17 mg/dL
Standard Error 0.42
|
12.56 mg/dL
Standard Error 0.46
|
12.13 mg/dL
Standard Error 0.48
|
|
Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL
Creatinine
|
0.46 mg/dL
Standard Error 0.01
|
0.49 mg/dL
Standard Error 0.01
|
0.46 mg/dL
Standard Error 0.01
|
0.46 mg/dL
Standard Error 0.01
|
|
Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL
Glucose
|
82.15 mg/dL
Standard Error 2.36
|
83.03 mg/dL
Standard Error 2.39
|
79.45 mg/dL
Standard Error 2.44
|
80.0 mg/dL
Standard Error 2.46
|
|
Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL
Bilirubin total
|
0.47 mg/dL
Standard Error 0.03
|
0.45 mg/dL
Standard Error 0.03
|
0.49 mg/dL
Standard Error 0.03
|
0.46 mg/dL
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Outcome measures
| Measure |
Intervention
n=50 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=50 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
Albumin, Total Protein, Hemoglobin, Mean Cell Hgb in g/dL
Total protein
|
7.15 g/dL
Standard Error 0.63
|
8.45 g/dL
Standard Error 0.65
|
7.07 g/dL
Standard Error 0.73
|
7.06 g/dL
Standard Error 0.76
|
|
Albumin, Total Protein, Hemoglobin, Mean Cell Hgb in g/dL
Hemoglobin
|
12.99 g/dL
Standard Error 0.17
|
12.96 g/dL
Standard Error 0.17
|
12.99 g/dL
Standard Error 0.18
|
12.91 g/dL
Standard Error 0.18
|
|
Albumin, Total Protein, Hemoglobin, Mean Cell Hgb in g/dL
Mean cell Hgb concentration
|
33.82 g/dL
Standard Error 0.13
|
33.59 g/dL
Standard Error 0.13
|
33.75 g/dL
Standard Error 0.15
|
33.47 g/dL
Standard Error 0.15
|
|
Albumin, Total Protein, Hemoglobin, Mean Cell Hgb in g/dL
Albumin
|
4.34 g/dL
Standard Error 0.17
|
4.34 g/dL
Standard Error 0.17
|
4.29 g/dL
Standard Error 0.17
|
4.28 g/dL
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Outcome measures
| Measure |
Intervention
n=50 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=50 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
AST, ALT, Alkaline in U/L
AST
|
23.58 U/L
Standard Error 1.26
|
27.28 U/L
Standard Error 1.28
|
25.72 U/L
Standard Error 1.42
|
22.79 U/L
Standard Error 1.46
|
|
AST, ALT, Alkaline in U/L
ALT
|
18.67 U/L
Standard Error 3.25
|
26.00 U/L
Standard Error 3.27
|
20.40 U/L
Standard Error 3.37
|
18.09 U/L
Standard Error 3.41
|
|
AST, ALT, Alkaline in U/L
Alkaline phosphatase
|
255 U/L
Standard Error 8.10
|
241.33 U/L
Standard Error 8.15
|
252.21 U/L
Standard Error 9.29
|
257.93 U/L
Standard Error 9.41
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Outcome measures
| Measure |
Intervention
n=50 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=50 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
RBC Count in Cells/mcL
|
4,650,000 cells/mcL
Standard Error 0.08
|
4,650,000 cells/mcL
Standard Error 0.08
|
4,600,000 cells/mcL
Standard Error 0.08
|
4,600,000 cells/mcL
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Outcome measures
| Measure |
Intervention
n=50 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=50 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent
Hematocrit
|
38.40 percent
Standard Error 0.52
|
38.60 percent
Standard Error 0.52
|
38.50 percent
Standard Error 0.55
|
38.60 percent
Standard Error 0.55
|
|
Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent
RBC distribution
|
25.03 percent
Standard Error 8.76
|
25.17 percent
Standard Error 8.76
|
25.29 percent
Standard Error 8.76
|
25.02 percent
Standard Error 8.76
|
|
Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent
Immature grans
|
0.20 percent
Standard Error 0.02
|
0.18 percent
Standard Error 0.02
|
0.24 percent
Standard Error 0.02
|
0.19 percent
Standard Error 0.03
|
|
Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent
Lymphocyte
|
43.63 percent
Standard Error 1.65
|
43.53 percent
Standard Error 1.66
|
40.25 percent
Standard Error 1.80
|
40.65 percent
Standard Error 1.84
|
|
Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent
Monocyte
|
8.03 percent
Standard Error 0.34
|
8.29 percent
Standard Error 0.34
|
7.78 percent
Standard Error 0.38
|
8.35 percent
Standard Error 0.38
|
|
Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent
Eosinophil
|
3.82 percent
Standard Error 0.63
|
4.03 percent
Standard Error 0.64
|
6.49 percent
Standard Error 0.73
|
5.71 percent
Standard Error 0.75
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Outcome measures
| Measure |
Intervention
n=50 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=50 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
Mean Cell Volume in fL
|
82.70 fL
Standard Error 0.44
|
83.00 fL
Standard Error 0.45
|
83.74 fL
Standard Error 0.49
|
83.85 fL
Standard Error 0.50
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Outcome measures
| Measure |
Intervention
n=50 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=50 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
Iron in ug/dL
|
99.1 ug/dL
Standard Error 4.65
|
90.7 ug/dL
Standard Error 4.69
|
100.5 ug/dL
Standard Error 5.35
|
95.5 ug/dL
Standard Error 5.49
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Outcome measures
| Measure |
Intervention
n=50 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=50 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
n=38 Participants
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
WBC Count, Absolute Monocyte, Absolute Eosinophil, Platelet Count in Cells/mcL
WBC count
|
5,710 cells/mcL
Standard Error 0.22
|
5,730 cells/mcL
Standard Error 0.23
|
6,080 cells/mcL
Standard Error 0.25
|
5,990 cells/mcL
Standard Error 0.26
|
|
WBC Count, Absolute Monocyte, Absolute Eosinophil, Platelet Count in Cells/mcL
Absolute monocyte
|
460 cells/mcL
Standard Error 0.02
|
470 cells/mcL
Standard Error 0.02
|
460 cells/mcL
Standard Error 0.02
|
480 cells/mcL
Standard Error 0.02
|
|
WBC Count, Absolute Monocyte, Absolute Eosinophil, Platelet Count in Cells/mcL
Absolute eosinophil
|
210 cells/mcL
Standard Error 0.04
|
230 cells/mcL
Standard Error 0.04
|
390 cells/mcL
Standard Error 0.04
|
340 cells/mcL
Standard Error 0.05
|
|
WBC Count, Absolute Monocyte, Absolute Eosinophil, Platelet Count in Cells/mcL
Platelet count
|
289,970 cells/mcL
Standard Error 7.54
|
289,320 cells/mcL
Standard Error 7.57
|
290,160 cells/mcL
Standard Error 8.62
|
295,900 cells/mcL
Standard Error 8.75
|
SECONDARY outcome
Timeframe: 16 weeksSecond primary measure is the blinded clinician-rated CGI-Improvement (CGI-I) is a subscale of the CGI that rates overall improvement of symptoms based on all relevant data. Item range is 1-7 (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse); lower score is better. A treatment responder is defined as a participant who is rated a 1 or 2 on the CGI-I. The CGI-Severity (CGI-S) subscale will also be scored at baseline and week 8, with scores compared at the two time points. Item range is 1-7 (normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients); lower score is better; most participants will be a 4 or 5 at baseline.
Outcome measures
| Measure |
Intervention
n=103 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
Clinical Global Impression (CGI)
|
103 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Primary outcome measure, defined a priori, reflecting the often-comorbid ADHD symptoms of emotional dysregulation irritable mood, anger or aggression), are the parent-rated Child and Adolescent Symptom Inventory (CASI-5) subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict. The CASI-5 is based on the DSM-5 symptom criteria. Item range is 0-3 (never, sometimes, often, very often). Higher scores represent a worse outcome. The subscales for ADHD, ODD, and DMD will be composite scores.
Outcome measures
| Measure |
Intervention
n=103 Participants
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Baseline)
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Placebo (Week 8)
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
|---|---|---|---|---|
|
CASI-5 Parent Report
Week 16
|
0.99 score on a scale
Standard Error 0.05
|
—
|
—
|
—
|
|
CASI-5 Parent Report
Week 12
|
1.14 score on a scale
Standard Error 0.04
|
—
|
—
|
—
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Open Label
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=69 participants at risk
Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
Placebo
n=54 participants at risk
Capsules of inactive placebo.
Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
|
Open Label
n=99 participants at risk
All participants have the option to participate in an 8-week, naturalistic, open label follow-up in which the child will take the active micronutrient treatment; capsules of broad spectrum micronutrients.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
|
|---|---|---|---|
|
General disorders
Other
|
7.2%
5/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
9.3%
5/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
2.0%
2/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
General disorders
Chest Pain
|
0.00%
0/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.0%
1/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
General disorders
Dizzy or light-headed
|
0.00%
0/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.0%
1/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Irritability
|
1.4%
1/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Angry or hostile
|
4.3%
3/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
2.0%
2/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Sad or low mood
|
2.9%
2/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
3.0%
3/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Lack of interest
|
2.9%
2/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.0%
1/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Mood swings
|
2.9%
2/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
2.0%
2/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Anxious, tense, or uptight
|
4.3%
3/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
2.0%
2/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Gastrointestinal disorders
GI symptoms
|
24.6%
17/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
14.8%
8/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
9.1%
9/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Lack of self-control/ impulsive
|
4.3%
3/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
3.7%
2/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.0%
1/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Nervous system disorders
Headache
|
1.4%
1/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
3.7%
2/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Trouble paying attention or concentrating
|
2.9%
2/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Racing thoughts
|
1.4%
1/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Can't sit or stand still
|
4.3%
3/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
General disorders
Tired/fatigued
|
2.9%
2/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
General disorders
Trouble falling asleep
|
5.8%
4/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Tried to hurt himself/ herself
|
1.4%
1/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.0%
1/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Hurt someone or something
|
1.4%
1/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.0%
1/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Metabolism and nutrition disorders
Less hungry
|
5.8%
4/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
4.0%
4/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Metabolism and nutrition disorders
Lost weight
|
0.00%
0/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Metabolism and nutrition disorders
Dry mouth
|
1.4%
1/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Metabolism and nutrition disorders
Gained weight
|
0.00%
0/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Nervous system disorders
Muscle shaking, stiffness, or cramps
|
0.00%
0/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Nervous system disorders
Tics
|
0.00%
0/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Psychiatric disorders
Unusually good mood or super happy
|
1.4%
1/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
2.0%
2/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin rash or irritation
|
1.4%
1/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.0%
1/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
|
Cardiac disorders
Heart racing or skipping beats
|
0.00%
0/69 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
1.9%
1/54 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
0.00%
0/99 • Baseline, week 1, week 4, week 8 and week 16
Used the Pediatric Adverse Events Rating Scale (PAERS) to assess treatment emergent adverse events.
|
Additional Information
Jeanette Johnstone, PhD
Oregon Health & Science University
Phone: 5034943700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place