Trial Outcomes & Findings for Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure (NCT NCT01149538)
NCT ID: NCT01149538
Last Updated: 2016-12-19
Results Overview
Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline, 6 months, & 9 months
Results posted on
2016-12-19
Participant Flow
Participant milestones
| Measure |
Choline Bitartrate
Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
|
Placebo
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Choline Bitartrate
Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
|
Placebo
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
Baseline Characteristics
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Baseline characteristics by cohort
| Measure |
Choline Bitartrate
n=31 Participants
Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
|
Placebo
n=29 Participants
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.79 years
STANDARD_DEVIATION .80 • n=5 Participants
|
3.92 years
STANDARD_DEVIATION .76 • n=7 Participants
|
3.855 years
STANDARD_DEVIATION .78 • n=5 Participants
|
|
Gender
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, & 9 monthsPopulation: Children with fetal alcohol spectrum disorders receiving either choline or placebo for 9 months
Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.
Outcome measures
| Measure |
Choline Bitartrate
n=31 Participants
Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
|
Placebo
n=29 Participants
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
|
|---|---|---|
|
Side Effects of Choline Bitartrate
Baseline musculoskeletal problems
|
0 participants
|
1 participants
|
|
Side Effects of Choline Bitartrate
6 month headaches/dizziness
|
2 participants
|
2 participants
|
|
Side Effects of Choline Bitartrate
Baseline energy level problems
|
8 participants
|
10 participants
|
|
Side Effects of Choline Bitartrate
6 month energy level problems
|
8 participants
|
9 participants
|
|
Side Effects of Choline Bitartrate
9 months energy level problems
|
8 participants
|
9 participants
|
|
Side Effects of Choline Bitartrate
Baseline pain
|
3 participants
|
4 participants
|
|
Side Effects of Choline Bitartrate
6 month pain
|
3 participants
|
4 participants
|
|
Side Effects of Choline Bitartrate
9 month pain
|
3 participants
|
4 participants
|
|
Side Effects of Choline Bitartrate
Baseline skin problems
|
6 participants
|
6 participants
|
|
Side Effects of Choline Bitartrate
6 month skin problems
|
6 participants
|
5 participants
|
|
Side Effects of Choline Bitartrate
9 month skin problems
|
6 participants
|
5 participants
|
|
Side Effects of Choline Bitartrate
Baseline Ear Nose Throat problems
|
1 participants
|
0 participants
|
|
Side Effects of Choline Bitartrate
6 month Ear Nose Throat problems
|
1 participants
|
0 participants
|
|
Side Effects of Choline Bitartrate
9 month Ear Nose Throat problems
|
1 participants
|
1 participants
|
|
Side Effects of Choline Bitartrate
Baseline headaches/dizziness
|
2 participants
|
2 participants
|
|
Side Effects of Choline Bitartrate
9 month headaches/dizziness
|
2 participants
|
2 participants
|
|
Side Effects of Choline Bitartrate
Baseline vision problems
|
2 participants
|
2 participants
|
|
Side Effects of Choline Bitartrate
6 month vision problems
|
0 participants
|
2 participants
|
|
Side Effects of Choline Bitartrate
9 month vision problems
|
0 participants
|
2 participants
|
|
Side Effects of Choline Bitartrate
Baseline cardiovascular
|
1 participants
|
1 participants
|
|
Side Effects of Choline Bitartrate
6 month cardiovascular
|
1 participants
|
1 participants
|
|
Side Effects of Choline Bitartrate
9 month cardiovascular
|
1 participants
|
1 participants
|
|
Side Effects of Choline Bitartrate
Baseline respiratory problems
|
6 participants
|
6 participants
|
|
Side Effects of Choline Bitartrate
6 month respiratory problems
|
6 participants
|
6 participants
|
|
Side Effects of Choline Bitartrate
9 month respiratory problems
|
6 participants
|
6 participants
|
|
Side Effects of Choline Bitartrate
Baseline gastrointestinal problems
|
18 participants
|
14 participants
|
|
Side Effects of Choline Bitartrate
6 month gastrointestinal problems
|
18 participants
|
11 participants
|
|
Side Effects of Choline Bitartrate
9 month gastrointestinal problems
|
18 participants
|
11 participants
|
|
Side Effects of Choline Bitartrate
Baseline genitourinary problems
|
4 participants
|
9 participants
|
|
Side Effects of Choline Bitartrate
6 month genitourinary problems
|
4 participants
|
8 participants
|
|
Side Effects of Choline Bitartrate
9 month genitourinary problems
|
4 participants
|
8 participants
|
|
Side Effects of Choline Bitartrate
6 month musculoskeletal problems
|
0 participants
|
1 participants
|
|
Side Effects of Choline Bitartrate
9 month musculoskeletal problems
|
0 participants
|
1 participants
|
|
Side Effects of Choline Bitartrate
6 month neurologic/psychiatric problems
|
11 participants
|
9 participants
|
|
Side Effects of Choline Bitartrate
9 month neurologic/psychiatric problems
|
11 participants
|
9 participants
|
|
Side Effects of Choline Bitartrate
Baseline neurologic/psychiatric problems
|
11 participants
|
9 participants
|
|
Side Effects of Choline Bitartrate
Baseline allergic problems
|
2 participants
|
3 participants
|
|
Side Effects of Choline Bitartrate
6 month allergic problems
|
0 participants
|
3 participants
|
|
Side Effects of Choline Bitartrate
9 month allergic problems
|
0 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline and 9 monthsPopulation: Including those with partial completion (drop-outs and lost-to-followup).
The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.
Outcome measures
| Measure |
Choline Bitartrate
n=31 Participants
Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
|
Placebo
n=29 Participants
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
|
|---|---|---|
|
Mullen Scales of Early Learning - Early Learning Composite
Baseline
|
83.2 units on a scale
Standard Deviation 13.7
|
84.3 units on a scale
Standard Deviation 21.4
|
|
Mullen Scales of Early Learning - Early Learning Composite
9-month follow-up
|
87.1 units on a scale
Standard Deviation 16.4
|
89.6 units on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: Baseline, 6 months, and 9 monthsPopulation: Young choline group (n=17); Young placebo group (n=13); Old choline group (n=14); Old placebo group (n=16).
The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5.
Outcome measures
| Measure |
Choline Bitartrate
n=31 Participants
Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
|
Placebo
n=29 Participants
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
|
|---|---|---|
|
Elicited Imitation Task Memory
Delayed-Items-Young
|
14.24 Slope
Standard Error 3.84
|
4.43 Slope
Standard Error 4.04
|
|
Elicited Imitation Task Memory
Delayed-Items-Old
|
-.71 Slope
Standard Error 3.98
|
4.23 Slope
Standard Error 3.90
|
|
Elicited Imitation Task Memory
Delayed-Pairs-Young
|
18.97 Slope
Standard Error 3.65
|
10.39 Slope
Standard Error 4.00
|
|
Elicited Imitation Task Memory
Delayed-Pairs-Old
|
2.69 Slope
Standard Error 3.79
|
7.79 Slope
Standard Error 3.73
|
|
Elicited Imitation Task Memory
Immed-Items-Young
|
8.48 Slope
Standard Error 4.23
|
13.72 Slope
Standard Error 4.41
|
|
Elicited Imitation Task Memory
Immed-Items-Old
|
2.59 Slope
Standard Error 4.36
|
3.89 Slope
Standard Error 4.24
|
|
Elicited Imitation Task Memory
Immed-Pairs-Young
|
8.75 Slope
Standard Error 4.45
|
20.01 Slope
Standard Error 4.80
|
|
Elicited Imitation Task Memory
Immed-Pairs-Old
|
11.46 Slope
Standard Error 4.61
|
5.50 Slope
Standard Error 4.46
|
SECONDARY outcome
Timeframe: Baseline, 6 months, and 9 monthsPopulation: Children with FASD who were administered Evoked Response Potential test and provided usable date (choline and placebo arms)
Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.
Outcome measures
| Measure |
Choline Bitartrate
n=36 Participants
Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
|
Placebo
n=35 Participants
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
|
|---|---|---|
|
Evoked Response Potentials Microvolts
Frontal Positive Slow Wave (PSW) - Baseline
|
-2.05 Mircovolts
Standard Deviation 5.49
|
0.57 Mircovolts
Standard Deviation 7.24
|
|
Evoked Response Potentials Microvolts
Frontal Positive Slow Wave (PSW) - 6 months
|
-1.04 Mircovolts
Standard Deviation 4.58
|
-1.03 Mircovolts
Standard Deviation 3.48
|
|
Evoked Response Potentials Microvolts
Frontal Positive Slow Wave (PSW) - 9 months
|
-0.26 Mircovolts
Standard Deviation 5.01
|
-1.41 Mircovolts
Standard Deviation 5.23
|
|
Evoked Response Potentials Microvolts
Frontal Neg Component Amplitude - Baseline
|
-2.53 Mircovolts
Standard Deviation 5.66
|
0.62 Mircovolts
Standard Deviation 7.56
|
|
Evoked Response Potentials Microvolts
Frontal Neg Component Amplitude - 6 months
|
1.22 Mircovolts
Standard Deviation 5.46
|
-0.84 Mircovolts
Standard Deviation 4.94
|
|
Evoked Response Potentials Microvolts
Frontal Neg Component Amplitude - 9 months
|
0.35 Mircovolts
Standard Deviation 5.53
|
-1.37 Mircovolts
Standard Deviation 5.08
|
SECONDARY outcome
Timeframe: Baseline, 6 months, and 9 monthsPopulation: Children with FASD who were administered Evoked Response Potential test and provided usable data (choline and placebo arms)
Evoked Response Potential - negative component latency data are included.
Outcome measures
| Measure |
Choline Bitartrate
n=36 Participants
Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
|
Placebo
n=35 Participants
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
|
|---|---|---|
|
Evoked Response Potential - Negative Component Latency
Frontal Neg Component Latency at baseline
|
2.23 Milliseconds
Standard Deviation 43.96
|
5.35 Milliseconds
Standard Deviation 60.21
|
|
Evoked Response Potential - Negative Component Latency
Frontal Neg Component at 6 months
|
32.45 Milliseconds
Standard Deviation 60.31
|
-4.28 Milliseconds
Standard Deviation 55.22
|
|
Evoked Response Potential - Negative Component Latency
Frontal Neg Component at 9 months
|
-4.00 Milliseconds
Standard Deviation 42.30
|
-3.03 Milliseconds
Standard Deviation 79.62
|
Adverse Events
Choline Bitartrate
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Choline Bitartrate
n=31 participants at risk
Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
|
Placebo
n=29 participants at risk
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skip problems
|
12.9%
4/31 • Number of events 4 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
13.8%
4/29 • Number of events 4 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
|
Ear and labyrinth disorders
Ear
|
3.2%
1/31 • Number of events 1 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
0.00%
0/29 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
|
Cardiac disorders
Cardiovascular
|
3.2%
1/31 • Number of events 1 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
0.00%
0/29 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
16.1%
5/31 • Number of events 5 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
13.8%
4/29 • Number of events 4 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
|
Gastrointestinal disorders
Gastrointestinal
|
29.0%
9/31 • Number of events 9 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
24.1%
7/29 • Number of events 7 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
|
Gastrointestinal disorders
Fishy Body Odor
|
48.4%
15/31 • Number of events 15 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
3.4%
1/29 • Number of events 1 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
|
Renal and urinary disorders
Genitourinary
|
9.7%
3/31 • Number of events 3 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
27.6%
8/29 • Number of events 8 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/31 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
0.00%
0/29 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
|
Nervous system disorders
Neurologic
|
19.4%
6/31 • Number of events 6 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
13.8%
4/29 • Number of events 4 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
|
Immune system disorders
Allergy
|
0.00%
0/31 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
6.9%
2/29 • Number of events 2 • Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place