Trial Outcomes & Findings for Management of Severe Acute Malnutrition in SCD, in Northern Nigeria (NCT NCT03634488)
NCT ID: NCT03634488
Last Updated: 2024-03-27
Results Overview
The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on mean corpuscular volume (MCV) values at exit (12 weeks).
COMPLETED
PHASE2
132 participants
Feasibility over 12-week Period [Time Frame: 3 months]
2024-03-27
Participant Flow
The first participant was enrolled in the "Management of Severe Acute Malnutrition in Children With Sickle Cell Disease Greater Than 5 Years of Age Living in Northern Nigeria" study in August 2021. Recruitment took place at Aminu Kano Teaching Hospital and Murtala Muhammad Specialist Hospital in Kano, Nigeria. Enrollment for children with SCD (either the Ready-to-Use Therapeutic Food arm or the Ready-to-Use Therapeutic Food and Hydroxyurea arm) and siblings without SCD ended in May 2022.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia.
Participant milestones
| Measure |
SCD: Ready-to-use Therapeutic Food and Hydroxyurea
At least 50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food (500-1,000 daily calories) and hydroxyurea (20mg/kg/day)
Hydroxyurea (20mg/kg/day): Treatment of severe malnutrition in children with SCA in northern Nigeria
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
SCD: Ready-to-use Therapeutic Food Alone
At least 50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food alone
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
Siblings Without SCD
Up to 100 non-SCD siblings(5-12 years old) and severe malnutrition will be enrolled.
Ready-to-use therapeutic food: Treatment of severe malnutrition in children without SCD in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
54
|
22
|
|
Overall Study
COMPLETED
|
54
|
54
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
SCD: Ready-to-use Therapeutic Food and Hydroxyurea
At least 50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food (500-1,000 daily calories) and hydroxyurea (20mg/kg/day)
Hydroxyurea (20mg/kg/day): Treatment of severe malnutrition in children with SCA in northern Nigeria
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
SCD: Ready-to-use Therapeutic Food Alone
At least 50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food alone
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
Siblings Without SCD
Up to 100 non-SCD siblings(5-12 years old) and severe malnutrition will be enrolled.
Ready-to-use therapeutic food: Treatment of severe malnutrition in children without SCD in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
A participant was administratively withdrawn due to a calculated BMI z-score >-3.0.
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SCD - Ready-to-use Therapeutic Food and Hydroxyurea
n=55 Participants
Children (5-12 years old) with SCA and severe malnutrition randomly allocated to receive Ready-to-use therapeutic food and hydroxyurea (20mg/kg/day)
hydroxyurea (20mg/kg/day): Treatment of severe malnutrition in children with SCA in northern Nigeria
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
SCD - Ready-to-use Therapeutic Food Alone
n=54 Participants
Children (5-12 years old) with SCA and severe malnutrition randomly allocated to receive Ready-to-use therapeutic food alone
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
Siblings Without SCD
n=22 Participants
non-SCD siblings(5-12 years old) with severe malnutrition.
Ready-to-use therapeutic food: Treatment of severe malnutrition in children without SCD in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.2 years
n=55 Participants
|
10.5 years
n=54 Participants
|
8.2 years
n=22 Participants
|
10.1 years
n=131 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=55 Participants
|
27 Participants
n=54 Participants
|
14 Participants
n=22 Participants
|
67 Participants
n=131 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=55 Participants
|
27 Participants
n=54 Participants
|
8 Participants
n=22 Participants
|
64 Participants
n=131 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Race/Ethnicity, Customized
Fulani
|
4 Participants
n=55 Participants
|
2 Participants
n=54 Participants
|
0 Participants
n=22 Participants
|
6 Participants
n=131 Participants
|
|
Race/Ethnicity, Customized
Hausa
|
49 Participants
n=55 Participants
|
51 Participants
n=54 Participants
|
22 Participants
n=22 Participants
|
122 Participants
n=131 Participants
|
|
Race/Ethnicity, Customized
Kanuri
|
1 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=131 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=55 Participants
|
1 Participants
n=54 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=131 Participants
|
|
Weight, kg, mean (std. dev.)
|
18.4 kg
STANDARD_DEVIATION 3.5 • n=55 Participants
|
18.7 kg
STANDARD_DEVIATION 3.5 • n=54 Participants
|
18.1 kg
STANDARD_DEVIATION 4.2 • n=22 Participants
|
18.5 kg
STANDARD_DEVIATION 3.6 • n=131 Participants
|
|
Height, cm, mean (std. dev.)
|
123.5 centimeters
STANDARD_DEVIATION 10.1 • n=55 Participants
|
124.1 centimeters
STANDARD_DEVIATION 9.5 • n=54 Participants
|
123.5 centimeters
STANDARD_DEVIATION 12.3 • n=22 Participants
|
123.7 centimeters
STANDARD_DEVIATION 10.2 • n=131 Participants
|
|
Body Mass Index, kg/m^2, mean (std. dev.)
|
12 kg/m^2
STANDARD_DEVIATION 0.6 • n=55 Participants
|
12.1 kg/m^2
STANDARD_DEVIATION 0.6 • n=54 Participants
|
11.7 kg/m^2
STANDARD_DEVIATION 0.6 • n=22 Participants
|
12 kg/m^2
STANDARD_DEVIATION 0.6 • n=131 Participants
|
|
Body Mass Index z-score, mean (std. dev.)
|
-3.64 Z-score
STANDARD_DEVIATION 0.49 • n=55 Participants
|
-3.66 Z-score
STANDARD_DEVIATION 0.44 • n=54 Participants
|
-3.6 Z-score
STANDARD_DEVIATION 0.5 • n=22 Participants
|
-3.65 Z-score
STANDARD_DEVIATION 0.46 • n=131 Participants
|
|
Hemoglobin, g/dl, mean (std. dev.)
|
7.4 g/dl
STANDARD_DEVIATION 1 • n=55 Participants
|
7.3 g/dl
STANDARD_DEVIATION 1.1 • n=54 Participants
|
10.8 g/dl
STANDARD_DEVIATION 1.0 • n=22 Participants
|
7.9 g/dl
STANDARD_DEVIATION 1.7 • n=131 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Children aged 5-12 years with SCA were evaluated for eligibility. Siblings of enrolled participants aged 5-12 years old without SCD were also evaluated for eligibility.
Recruitment Feasibility: The primary outcome is the proportion of eligible individuals that agree to be included, referred to as the recruitment rate. Children with severe malnutrition who qualified and agreed to participate were invited to sign a consent and assent for study recruitment to this study.
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=111 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=22 Participants
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Enrollment Rate at the End of the 6-month Recruitment Period
Unable to randomize
|
1 participants
|
0 participants
|
—
|
|
Enrollment Rate at the End of the 6-month Recruitment Period
Eligible
|
111 participants
|
22 participants
|
—
|
|
Enrollment Rate at the End of the 6-month Recruitment Period
Randomized
|
110 participants
|
22 participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The analysis included participants with sickle cell anemia and severe acute malnutrition. The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia.
The primary outcome is the proportion of participants who completed the 12-week trial, known as the retention rate for the trial.
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=56 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=54 Participants
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
n=22 Participants
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Retention Over 12-week Period
Voluntarily withdrew from the trial
|
0 participants
|
0 participants
|
0 participants
|
|
Retention Over 12-week Period
Involuntary withdrawal from the trial
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The final analysis included 54 participants with sickle cell anemia from each arm with sickle cell anemia and severe acute malnutrition, along with 22 non-SCD siblings with severe acute malnutrition.
Adherence to the ready-to-use therapeutic food was evaluated based on the percentage of empty food sachets returned at each visit.
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=54 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=54 Participants
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
n=22 Participants
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Percentage of Ready-to-use Therapeutic Food Sachets Returned as Empty.
|
99.02 percentage of empty sachets
Interval 99.0 to 99.04
|
99.03 percentage of empty sachets
Interval 99.0 to 99.05
|
99.02 percentage of empty sachets
Interval 99.01 to 99.04
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Per-protocol analysis of participants.
Adherence to monthly visits was assessed based on the number of missed visits
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=216 Research Visits
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=216 Research Visits
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
n=88 Research Visits
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Number of Missed Visits
|
0 missed visits
|
0 missed visits
|
0 missed visits
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The final analysis included 54 participants with sickle cell anemia and severe acute malnutrition randomized to receive hydroxyurea in addition to ready-to-use therapeutic food. The other arms did not receive hydroxyurea, and therefore, adherence to hydroxyurea cannot be evaluated.
Adherence to hydroxyurea was evaluated based on the percentage of hydroxyurea pills returned for the group randomized to both ready-to-use therapeutic food and hydroxyurea.
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=54 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Percentage of Hydroxyurea Pills Returned
|
4.4 percentage of hydroxyurea pills returned
Interval 0.0 to 8.27
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The final analysis included 54 participants from each arm with sickle cell anemia and severe acute malnutrition. We did not include the siblings' change in mean corpuscular volume - since none of the siblings without sickle cell disease received hydroxyurea.
Adherence to hydroxyurea was evaluated based on change in mean corpuscular volume
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=54 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=54 Participants
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Change in Mean Corpuscular Volume
|
5.4 fl
Standard Deviation 12.7
|
-1.0 fl
Standard Deviation 10.9
|
—
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPopulation: The final analysis included 54 participants from each arm with sickle cell anemia and severe acute malnutrition. We did not measure fetal hemoglobin in children without SCD.
The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on the change in fetal hemoglobin level percentage.
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=54 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=54 Participants
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Change in Fetal Hemoglobin Level Percentage
|
3.9 percentage of fetal hemoglobin
Interval 1.7 to 6.8
|
2.2 percentage of fetal hemoglobin
Interval 0.5 to 4.9
|
—
|
PRIMARY outcome
Timeframe: Feasibility over 12-week Period [Time Frame: 3 months]Population: The final analysis included 54 participants from each arm with sickle cell anemia and severe acute malnutrition. The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in these main results.
The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on mean corpuscular volume (MCV) values at exit (12 weeks).
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=54 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=54 Participants
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Mean Corpuscular Volume Values at Exit
|
88.5 fl
Standard Deviation 14.7
|
85.4 fl
Standard Deviation 11.4
|
—
|
PRIMARY outcome
Timeframe: Feasibility over 12-week Period [Time Frame: 3 months]Population: The final analysis included 54 participants from each arm with sickle cell anemia and severe acute malnutrition. The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in these main results.
The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on the fetal hemoglobin levels at exit (12 weeks).
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=54 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=54 Participants
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Fetal Hemoglobin Levels at Exit
|
12.2 percentage of fetal hemoglobin
Interval 7.5 to 16.9
|
9.4 percentage of fetal hemoglobin
Interval 5.6 to 13.8
|
—
|
PRIMARY outcome
Timeframe: Feasibility over 12-week Period [Time Frame: 3 months]Population: The final analysis included 54 participants from each arm with sickle cell anemia and severe acute malnutrition. The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in these main results.
The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on the total hemoglobin levels at exit (12 weeks).
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=54 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=54 Participants
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Total Hemoglobin Levels at Exit
|
8.3 g/dl
Standard Deviation 1.1
|
7.7 g/dl
Standard Deviation 1.3
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The final analysis included 54 participants with sickle cell anemia from each arm with sickle cell anemia and severe acute malnutrition, along with 22 non-SCD siblings with severe acute malnutrition.
As a secondary outcome, we assessed the percentage of participants with and without SCA who continued to have a body mass index z-score of \<-3.0 at the end of the 12 weeks of treatment. Using the World Health Organization (WHO) growth reference, anthropometric measurements were converted to age and sex-specific z-scores. Anthropometric Indices (BMI-for-age (BMIZ), were calculated using WHO 2007 R Macro Package to assess growth and development of the children. Severe malnutrition/wasting (SAM) was defined as a body mass index (BMI) z-score \<-3.0.
Outcome measures
| Measure |
Eligible Children Aged 5-12 Years With SCA
n=54 Participants
Children with SCA who met the criteria to participate in the study
|
Eligible Children Aged 5-12 Years Old Without SCD
n=54 Participants
Non-SCD siblings of participants with SCA who met the criteria to participate in the study
|
Siblings Without SCD
n=22 Participants
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Percentage of Participants Maintaining a BMI Z-score Less Than -3.0
|
66.7 percentage of participants
|
55.6 percentage of participants
|
30.1 percentage of participants
|
Adverse Events
Ready-to-use Therapeutic Food and Hydroxyurea
Ready-to-use Therapeutic Food Alone
Siblings Without SCD
Serious adverse events
| Measure |
Ready-to-use Therapeutic Food and Hydroxyurea
n=56 participants at risk
50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food and hydroxyurea (20mg/kg/day)
hydroxyurea (20mg/kg/day): Treatment of severe malnutrition in children with SCA in northern Nigeria
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
Ready-to-use Therapeutic Food Alone
n=54 participants at risk
50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food alone
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
Siblings Without SCD
n=22 participants at risk
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Prolonged hospitalization
|
1.8%
1/56 • Number of events 1 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
0.00%
0/54 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
0.00%
0/22 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
Other adverse events
| Measure |
Ready-to-use Therapeutic Food and Hydroxyurea
n=56 participants at risk
50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food and hydroxyurea (20mg/kg/day)
hydroxyurea (20mg/kg/day): Treatment of severe malnutrition in children with SCA in northern Nigeria
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
Ready-to-use Therapeutic Food Alone
n=54 participants at risk
50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food alone
Ready-to-use therapeutic food: Treatment of severe malnutrition in children with SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food
|
Siblings Without SCD
n=22 participants at risk
Non-SCD siblings (5-12 years old) with severe malnutrition enrolled to receive Ready-to-use therapeutic food (500-1,000 daily calories) only.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Pain
|
1.8%
1/56 • Number of events 1 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
3.7%
2/54 • Number of events 2 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
0.00%
0/22 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
|
Blood and lymphatic system disorders
Acute Chest Syndrome
|
1.8%
1/56 • Number of events 1 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
0.00%
0/54 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
0.00%
0/22 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
|
General disorders
Fever
|
3.6%
2/56 • Number of events 2 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
5.6%
3/54 • Number of events 3 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
0.00%
0/22 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
|
Ear and labyrinth disorders
Elective Surgery
|
0.00%
0/56 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
1.9%
1/54 • Number of events 1 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
0.00%
0/22 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
1/56 • Number of events 1 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
1.9%
1/54 • Number of events 1 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
0.00%
0/22 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
|
Infections and infestations
Malaria
|
3.6%
2/56 • Number of events 2 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
5.6%
3/54 • Number of events 3 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
0.00%
0/22 • The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment.
The feasibility trial's primary objectives are to evaluate the intervention's feasibility and safety in children with sickle cell anemia. We, therefore, did not include the outcomes for the siblings in the main results.
|
Additional Information
Leshana Saint Jean
Vanderbilt UniversityVanderbilt-Meharry Center of Excellence in Sickle Cell Disease
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place