Trial Outcomes & Findings for Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders (NCT NCT02735473)
NCT ID: NCT02735473
Last Updated: 2022-11-01
Results Overview
Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Change from baseline to 6 months in percentage correct
Results posted on
2022-11-01
Participant Flow
Participant milestones
| Measure |
Choline Bitartrate
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Choline bitartrate
|
Placebo
Powdered drink mix containing matching placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Choline Bitartrate
n=17 Participants
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Choline bitartrate
|
Placebo
n=16 Participants
Powdered drink mix containing matching placebo
Placebo
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 6 months in percentage correctElicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct.
Outcome measures
| Measure |
Choline Bitartrate
n=17 Participants
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Choline bitartrate
|
Placebo
n=16 Participants
Powdered drink mix containing matching placebo
Placebo
|
|---|---|---|
|
Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months
|
0.252 change in percentage correct
Standard Deviation 0.578
|
0.183 change in percentage correct
Standard Deviation 0.213
|
PRIMARY outcome
Timeframe: Change from baseline to 9 monthsElicited Imitation memory paradigm - short delay memory measure at 9 months
Outcome measures
| Measure |
Choline Bitartrate
n=17 Participants
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Choline bitartrate
|
Placebo
n=16 Participants
Powdered drink mix containing matching placebo
Placebo
|
|---|---|---|
|
Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months
|
0.318 change in percentage correct
Standard Deviation 0.126
|
0.668 change in percentage correct
Standard Deviation 0.372
|
SECONDARY outcome
Timeframe: Change from baseline to 9 months in IQ pointsStanford-Binet Intelligence Scales at 9 months; scores are standardized scores (mean 100 points, standard deviation of 15 points)
Outcome measures
| Measure |
Choline Bitartrate
n=16 Participants
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Choline bitartrate
|
Placebo
n=16 Participants
Powdered drink mix containing matching placebo
Placebo
|
|---|---|---|
|
Stanford-Binet Intelligence Scales: 9 Months
|
0.198 Percentage change in full-scale IQ point
Standard Deviation 0.175
|
0.008 Percentage change in full-scale IQ point
Standard Deviation 0.172
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: This measure was not collected at the 6-month visit but was completed at the 9-month visit.
Minnesota Executive Function Scale - Early Childhood Version at 6 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 9 months in t-score pointsMinnesota Executive Function Scale - Early Childhood Version at 9 months; scores are in t-scores (mean=50, standard deviation=10)
Outcome measures
| Measure |
Choline Bitartrate
n=16 Participants
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Choline bitartrate
|
Placebo
n=14 Participants
Powdered drink mix containing matching placebo
Placebo
|
|---|---|---|
|
Minnesota Executive Function Scale: 9 Months
|
0.007 Percentage change in overall score
Standard Deviation 0.091
|
0.017 Percentage change in overall score
Standard Deviation 0.177
|
SECONDARY outcome
Timeframe: Change from baseline to 9 months in fully-corrected t-score pointsNIH Toolbox Flanker Inhibitory and Control Task at 9 months; scores are fully-corrected t-scores (mean=40, standard deviation=10)
Outcome measures
| Measure |
Choline Bitartrate
n=13 Participants
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Choline bitartrate
|
Placebo
n=11 Participants
Powdered drink mix containing matching placebo
Placebo
|
|---|---|---|
|
NIH Toolbox Flanker Task: 9 Months
|
0.091 Percentage change in fully-corrected t-s
Standard Deviation 0.372
|
-0.169 Percentage change in fully-corrected t-s
Standard Deviation 0.641
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: This measure was not collected at the 6-month visit. It was, however, collected at the 9-month visit.
NIH Toolbox Flanker Inhibitory and Control Task at 6 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: This measure was not collected at the 6-month visit. It was collected at the 9-month visit.
Child Behavior Checklist - parent report instrument at 6 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 9 months in t-score pointsChild Behavior Checklist - parent report instrument at 9 months; scores are t-scores (mean=50, standard deviation=10)
Outcome measures
| Measure |
Choline Bitartrate
n=14 Participants
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Choline bitartrate
|
Placebo
n=16 Participants
Powdered drink mix containing matching placebo
Placebo
|
|---|---|---|
|
Child Behavior Checklist: 9 Months
|
-1.9 Change from baseline in t-score points
Standard Deviation 8.9
|
-1.8 Change from baseline in t-score points
Standard Deviation 7.35
|
Adverse Events
Choline Bitartrate
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Choline Bitartrate
n=23 participants at risk
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Choline bitartrate
|
Placebo
n=23 participants at risk
Powdered drink mix containing matching placebo
Placebo
|
|---|---|---|
|
General disorders
Fishy body odor
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
|
General disorders
Hyper/hypo-activity
|
30.4%
7/23 • Number of events 11 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
30.4%
7/23 • Number of events 8 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
|
Psychiatric disorders
Mood Changed
|
17.4%
4/23 • Number of events 9 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
30.4%
7/23 • Number of events 8 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
|
General disorders
Headaches
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
|
Gastrointestinal disorders
Stomach ache
|
13.0%
3/23 • Number of events 9 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
13.0%
3/23 • Number of events 5 • Adverse event data were collected of the 9 months of the study + 1 additional month post-study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place