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Trial record 19 of 36 for:    fetal alcohol children

Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01149538
Recruitment Status : Completed
First Posted : June 23, 2010
Results First Posted : August 11, 2016
Last Update Posted : December 19, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Fetal Alcohol Spectrum Disorders
Fetal Alcohol Syndrome
Partial Fetal Alcohol Syndrome
Alcohol Related Neurodevelopmental Disorder
Prenatal Alcohol Exposure
Interventions Drug: Choline bitartrate
Dietary Supplement: Placebo for choline bitartrate
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Choline Bitartrate Placebo
Hide Arm/Group Description

Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Placebo for choline bitartrate supplementation

Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Period Title: Overall Study
Started 31 29
Completed 26 25
Not Completed 5 4
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             5             3
Arm/Group Title Choline Bitartrate Placebo Total
Hide Arm/Group Description

Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Placebo for choline bitartrate supplementation

Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Total of all reporting groups
Overall Number of Baseline Participants 31 29 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 29 participants 60 participants
3.79  (.80) 3.92  (.76) 3.855  (.78)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
Female
19
  61.3%
19
  65.5%
38
  63.3%
Male
12
  38.7%
10
  34.5%
22
  36.7%
1.Primary Outcome
Title Side Effects of Choline Bitartrate
Hide Description Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.
Time Frame Baseline, 6 months, & 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Children with fetal alcohol spectrum disorders receiving either choline or placebo for 9 months
Arm/Group Title Choline Bitartrate Placebo
Hide Arm/Group Description:

Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Placebo for choline bitartrate supplementation

Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Overall Number of Participants Analyzed 31 29
Measure Type: Number
Unit of Measure: participants
Baseline energy level problems 8 10
6 month energy level problems 8 9
9 months energy level problems 8 9
Baseline pain 3 4
6 month pain 3 4
9 month pain 3 4
Baseline skin problems 6 6
6 month skin problems 6 5
9 month skin problems 6 5
Baseline Ear Nose Throat problems 1 0
6 month Ear Nose Throat problems 1 0
9 month Ear Nose Throat problems 1 1
Baseline headaches/dizziness 2 2
6 month headaches/dizziness 2 2
9 month headaches/dizziness 2 2
Baseline vision problems 2 2
6 month vision problems 0 2
9 month vision problems 0 2
Baseline cardiovascular 1 1
6 month cardiovascular 1 1
9 month cardiovascular 1 1
Baseline respiratory problems 6 6
6 month respiratory problems 6 6
9 month respiratory problems 6 6
Baseline gastrointestinal problems 18 14
6 month gastrointestinal problems 18 11
9 month gastrointestinal problems 18 11
Baseline genitourinary problems 4 9
6 month genitourinary problems 4 8
9 month genitourinary problems 4 8
Baseline musculoskeletal problems 0 1
6 month musculoskeletal problems 0 1
9 month musculoskeletal problems 0 1
6 month neurologic/psychiatric problems 11 9
9 month neurologic/psychiatric problems 11 9
Baseline neurologic/psychiatric problems 11 9
Baseline allergic problems 2 3
6 month allergic problems 0 3
9 month allergic problems 0 3
2.Primary Outcome
Title Mullen Scales of Early Learning - Early Learning Composite
Hide Description 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.
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Including those with partial completion (drop-outs and lost-to-followup).
Arm/Group Title Choline Bitartrate Placebo
Hide Arm/Group Description:

Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Placebo for choline bitartrate supplementation

Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 83.2  (13.7) 84.3  (21.4)
9-month follow-up 87.1  (16.4) 89.6  (21.6)
3.Secondary Outcome
Title Elicited Imitation Task Memory
Hide Description 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.
Time Frame Baseline, 6 months, and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Young choline group (n=17); Young placebo group (n=13); Old choline group (n=14); Old placebo group (n=16).
Arm/Group Title Choline Bitartrate Placebo
Hide Arm/Group Description:

Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Placebo for choline bitartrate supplementation

Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Overall Number of Participants Analyzed 31 29
Mean (Standard Error)
Unit of Measure: Slope
Delayed-Items-Young 14.24  (3.84) 4.43  (4.04)
Delayed-Items-Old -.71  (3.98) 4.23  (3.90)
Delayed-Pairs-Young 18.97  (3.65) 10.39  (4.00)
Delayed-Pairs-Old 2.69  (3.79) 7.79  (3.73)
Immed-Items-Young 8.48  (4.23) 13.72  (4.41)
Immed-Items-Old 2.59  (4.36) 3.89  (4.24)
Immed-Pairs-Young 8.75  (4.45) 20.01  (4.80)
Immed-Pairs-Old 11.46  (4.61) 5.50  (4.46)
4.Secondary Outcome
Title Evoked Response Potentials Microvolts
Hide Description Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.
Time Frame Baseline, 6 months, and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Children with FASD who were administered Evoked Response Potential test and provided usable date (choline and placebo arms)
Arm/Group Title Choline Bitartrate Placebo
Hide Arm/Group Description:

Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Placebo for choline bitartrate supplementation

Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: Mircovolts
Frontal Positive Slow Wave (PSW) - Baseline -2.05  (5.49) 0.57  (7.24)
Frontal Positive Slow Wave (PSW) - 6 months -1.04  (4.58) -1.03  (3.48)
Frontal Positive Slow Wave (PSW) - 9 months -0.26  (5.01) -1.41  (5.23)
Frontal Neg Component Amplitude - Baseline -2.53  (5.66) 0.62  (7.56)
Frontal Neg Component Amplitude - 6 months 1.22  (5.46) -0.84  (4.94)
Frontal Neg Component Amplitude - 9 months 0.35  (5.53) -1.37  (5.08)
5.Secondary Outcome
Title Evoked Response Potential - Negative Component Latency
Hide Description Evoked Response Potential - negative component latency data are included.
Time Frame Baseline, 6 months, and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Children with FASD who were administered Evoked Response Potential test and provided usable data (choline and placebo arms)
Arm/Group Title Choline Bitartrate Placebo
Hide Arm/Group Description:

Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Placebo for choline bitartrate supplementation

Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: Milliseconds
Frontal Neg Component Latency at baseline 2.23  (43.96) 5.35  (60.21)
Frontal Neg Component at 6 months 32.45  (60.31) -4.28  (55.22)
Frontal Neg Component at 9 months -4.00  (42.30) -3.03  (79.62)
Time Frame Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse Event Reporting Description 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).
 
Arm/Group Title Choline Bitartrate Placebo
Hide Arm/Group Description

Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Placebo for choline bitartrate supplementation

Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

All-Cause Mortality
Choline Bitartrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Choline Bitartrate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Choline Bitartrate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/31 (48.39%)      13/29 (44.83%)    
Cardiac disorders     
Cardiovascular  1 [1]  1/31 (3.23%)  1 0/29 (0.00%)  0
Ear and labyrinth disorders     
Ear  1 [2]  1/31 (3.23%)  1 0/29 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal  1 [3]  9/31 (29.03%)  9 7/29 (24.14%)  7
Fishy Body Odor  1 [4]  15/31 (48.39%)  15 1/29 (3.45%)  1
Immune system disorders     
Allergy  1 [5]  0/31 (0.00%)  0 2/29 (6.90%)  2
Musculoskeletal and connective tissue disorders     
Musculoskeletal  1 [6]  0/31 (0.00%)  0 0/29 (0.00%)  0
Nervous system disorders     
Neurologic  1 [7]  6/31 (19.35%)  6 4/29 (13.79%)  4
Renal and urinary disorders     
Genitourinary  1 [8]  3/31 (9.68%)  3 8/29 (27.59%)  8
Respiratory, thoracic and mediastinal disorders     
Respiratory  1 [9]  5/31 (16.13%)  5 4/29 (13.79%)  4
Skin and subcutaneous tissue disorders     
Skip problems  1 [10]  4/31 (12.90%)  4 4/29 (13.79%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
[1]
Heart racing, rhythm disturbance, swelling
[2]
Sore throat, congestion, eye watering, dry eyes
[3]
upset stomach, salivary changes, appetite change, diarrhea, constipation
[4]
Fishy body odor (a common result of choline supplementation)
[5]
flushing, itching, changes in tolerance to heat or cold
[6]
pain, joint swelling, weakness, cramps
[7]
seizures, coordination problems, worsening of mood/behavior
[8]
changes in urination pattern, incontinence, color changes
[9]
Shortness of breath, wheezing, cough
[10]
Rash, sweating, nail changes
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jeffrey R. Wozniak, Ph.D.
Organization: University of Minnesota
Phone: 612-273-9741
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01149538     History of Changes
Other Study ID Numbers: 0910M73517
R21AA019580 ( U.S. NIH Grant/Contract )
First Submitted: June 21, 2010
First Posted: June 23, 2010
Results First Submitted: February 29, 2016
Results First Posted: August 11, 2016
Last Update Posted: December 19, 2016