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Trial record 36 of 76 for:    Long-chain fatty acids

Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes

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: NCT01576783
Recruitment Status : Completed
First Posted : April 12, 2012
Results First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborators:
Allen Foundation Inc.
March of Dimes
Cures Within Reach
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Preterm Birth
Child Development
Interventions Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Dietary Supplement: Placebo
Enrollment 377
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Docosahexaenoic Acid + Arachidonic Acid Placebo
Hide Arm/Group Description

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months

Corn oil supplement

Placebo: 400 mg corn oil per day for 6 months

Period Title: Overall Study
Started 189 188
Completed 169 171
Not Completed 20 17
Reason Not Completed
Change in Medical Care             1             0
Lost to Follow-up             14             16
Withdrawal by Subject             5             1
Arm/Group Title Docosahexaenoic Acid + Arachidonic Acid Placebo Total
Hide Arm/Group Description

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months

Corn oil supplement

Placebo: 400 mg corn oil per day for 6 months

Total of all reporting groups
Overall Number of Baseline Participants 189 188 377
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 189 participants 188 participants 377 participants
15.7
(13.8 to 16.5)
15.6
(13.1 to 16.5)
15.7
(13.6 to 16.5)
[1]
Measure Description: Maximum age was 16 completed months, meaning someone who was 16 months and 29 days could be eligible to participate because they did not reach 17 months
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
Female
84
  44.4%
98
  52.1%
182
  48.3%
Male
105
  55.6%
90
  47.9%
195
  51.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
Hispanic or Latino
7
   3.7%
10
   5.3%
17
   4.5%
Not Hispanic or Latino
182
  96.3%
178
  94.7%
360
  95.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   1.1%
1
   0.5%
3
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
52
  27.5%
53
  28.2%
105
  27.9%
White
114
  60.3%
122
  64.9%
236
  62.6%
More than one race
21
  11.1%
12
   6.4%
33
   8.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 189 participants 188 participants 377 participants
189 188 377
1.Primary Outcome
Title Erythrocyte Fatty Acid Levels
Hide Description This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Time Frame Baseline to 180 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Rows titles are fatty acids with different C:D ratio where, "C"= Carbohydrate; "D" = Double bond; "C:D" is the ratio of the total amount of Carbon atoms of the fatty acid in relation to the number of double (unsaturated) bonds in it. Funding allotted for 205 children to be randomized to provide blood specimens but only 173 gave pre and post samples
Arm/Group Title Docosahexaenoic Acid + Arachidonic Acid Placebo
Hide Arm/Group Description:

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months

Corn oil supplement

Placebo: 400 mg corn oil per day for 6 months

Overall Number of Participants Analyzed 85 88
Mean (Standard Deviation)
Unit of Measure: nmol/mL
Linoleic acid (18:2n-6) -2.1  (5.2) 0.6  (4.4)
Arachidonic acid (20:4n-6) 2.0  (2.6) -0.2  (1.1)
Total n-6 0.2  (6.0) 0.4  (5.0)
α-linolenic acid (18:3n-3) -0.1  (0.4) 0.0  (0.3)
Eicosapentaenoic acid (20:5n-3) 0.0  (0.1) -0.1  (0.2)
Docosapentaenoic acid (22:5n-3) -0.1  (0.1) 0.0  (0.1)
Docosahexaenoic acid (22:6n-3) 1.1  (1.0) -0.1  (0.2)
Total n-3 0.9  (1.1) -0.2  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Linoleic acid (18:2n-6) mol% between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-3.4 to 0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Arachidonic acid (20:4n-6) mol% between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
1.7 to 2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Total n-6 mol% between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value 0.61
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in α-linolenic acid (18:3n-3) between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value 0.40
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.1 to 0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Eicosapentaenoic acid (20:5n-3) between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value 0.12
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.0 to 0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Docosapentaenoic acid (22:5n-3) between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.0
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Docosahexaenoic acid (22:6n-3) between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
1.0 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Total n-3 between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.9 to 1.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Erythrocyte Fatty Acid Levels (Additional Data)
Hide Description This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Time Frame Baseline to 180 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Rows titles are fatty acids with different C:D ratio where, "C"= Carbohydrate; "D" = Double bond; "C:D" is the ratio of the total amount of Carbon atoms of the fatty acid in relation to the number of double (unsaturated) bonds in it. Funding allotted for 205 children to be randomized to provide blood specimens but only 173 gave pre and post samples
Arm/Group Title Docosahexaenoic Acid + Arachidonic Acid Placebo
Hide Arm/Group Description:

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months

Corn oil supplement

Placebo: 400 mg corn oil per day for 6 months

Overall Number of Participants Analyzed 85 88
Mean (Standard Deviation)
Unit of Measure: ratio
-3.2  (3.9) 1.6  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in n-6:n-3 ratio between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.6
Confidence Interval (2-Sided) 95%
-5.5 to -3.7
Estimation Comments [Not Specified]
3.Primary Outcome
Title Enrollment and Trial Completion
Hide Description The number of children who enroll in the trial and the number of those children who return for study visits 2 and 3. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc.
Time Frame Baseline to 180 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docosahexaenoic Acid + Arachidonic Acid Placebo
Hide Arm/Group Description:

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months

Corn oil supplement

Placebo: 400 mg corn oil per day for 6 months

Overall Number of Participants Analyzed 189 188
Measure Type: Count of Participants
Unit of Measure: Participants
Study Visit 2 Completion
172
  91.0%
163
  86.7%
Study Visit 3 Completion
166
  87.8%
168
  89.4%
4.Primary Outcome
Title Adherence
Hide Description The mean (average) percentage of packets consumed by the children assigned to the supplement or placebo. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Time Frame Baseline to 180 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docosahexaenoic Acid + Arachidonic Acid Placebo
Hide Arm/Group Description:

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months

Corn oil supplement

Placebo: 400 mg corn oil per day for 6 months

Overall Number of Participants Analyzed 189 188
Mean (Standard Deviation)
Unit of Measure: average percentage of packets consumed
80.6  (28) 80.7  (25)
5.Secondary Outcome
Title (Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)
Hide Description Infant Behavior Questionnaire-Revised (IBQ-R; short form) was used to assess effortful control (12 items) and activity level (3 items). The IBQ-R measures early temperament-based inhibitory control,a key component of executive function as children mature. Scores range from 1 to 7, with higher scores indicating greater frequency of behaviors. IBQ-R scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the IBQ-R value at 180 days minus the IBQ-R value at baseline).
Time Frame Baseline to 180 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docosahexaenoic Acid + Arachidonic Acid Placebo
Hide Arm/Group Description:

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months

Corn oil supplement

Placebo: 400 mg corn oil per day for 6 months

Overall Number of Participants Analyzed 189 188
Mean (Standard Deviation)
Unit of Measure: units on a scale
Effortful Control -0.7  (0.8) -0.5  (0.8)
Activity Level 0.6  (1.5) 0.5  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Effortful Control Composite scores between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value .13
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Activity Level Composite scores between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value .76
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title (Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)
Hide Description Bayley Scales of Infant and Toddler Development, third edition, (Bayley-III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items,score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit. Bayley-III scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the Bayley-III value at 180 days minus the Bayley-III value at baseline). Secondary Outcome for 1st stage of project funded by Allen Foundation, Inc; Primary Outcome for 2nd stage of project funded by March of Dimes and Health Resources and Services Administration
Time Frame Baseline to 180 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docosahexaenoic Acid + Arachidonic Acid Placebo
Hide Arm/Group Description:

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months

Corn oil supplement

Placebo: 400 mg corn oil per day for 6 months

Overall Number of Participants Analyzed 189 188
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cognitive Composite -2.6  (13.3) -3.7  (12.2)
Language Composite -0.5  (12.0) 0.2  (12.6)
Motor Composite -0.6  (12.5) -0.4  (12.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments A sample of 448 was planned to achieve >80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Cognitive Composite scores between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value .66
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments A sample of 448 was planned to achieve >80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Language Composite scores between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value .55
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Docosahexaenoic Acid + Arachidonic Acid, Placebo
Comments A sample of 448 was planned to achieve >80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.
Type of Statistical Test Other
Comments The reported p-value is for the comparison of the change in Motor Composite scores between groups (DHA+AA vs. Placebo).
Statistical Test of Hypothesis P-Value .88
Comments Threshold for statistical significance (<0.05)
Method Mixed Models Analysis
Comments Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.
7.Other Pre-specified Outcome
Title Body Composition
Hide Description Changes in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds).
Time Frame Baseline to 180 days post-randomization
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Long-term Efficacy in Improving Cognition
Hide Description Long-term (26-32 months of age) cognitive outcome. This will be evaluated based on scores from the cognitive section of the Developmental Profile – 3.
Time Frame Long-term effect (6 months +) after intervention completion
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Long-term Efficacy in Improving Executive Functions
Hide Description Long-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the Behavior Rating Inventory of Executive Function – Preschool Version (BRIEF-P).
Time Frame Long-term effect (6 months +) after intervention completion
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Long-term Efficacy in Improving Executive Functions
Hide Description Long-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the ADHD DSM oriented subscale of the Child Behavior Checklist 1.5-5 (CBCL).
Time Frame Long-term effect (6 months +) after intervention completion
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Other Long-term Outcomes: Pervasive Developmental Problems
Hide Description Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Pervasive Developmental Problems DSM oriented scale on the Child Behavior Checklist 1.5-5 (CBCL).
Time Frame Long-term effect (6 months +) after intervention completion
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Other Long-term Outcomes: Language
Hide Description Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Communicative Development Inventory (CDI).
Time Frame Long-term effect (6 months +) after intervention completion
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Other Long-term Outcomes: Sleep
Hide Description Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Brief Infant Sleep Questionnaire (BISQ).
Time Frame Long-term effect (6 months +) after intervention completion
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Other Long-term Outcomes: Sleep
Hide Description Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Children’s Sleep Habits Questionnaire (CSHQ).
Time Frame Long-term effect (6 months +) after intervention completion
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title Other Long-term Outcomes: Developmental Delay
Hide Description Long-term (26-32 months of age) outcomes. This will be evaluated using reports/diagnoses of developmental delay.
Time Frame Long-term effect (6 months +) after intervention completion
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Other Long-term Outcomes: Behavior
Hide Description Long-term (26-32 months of age) outcomes. This will be evaluated using reports/diagnoses of behavioral difficulties.
Time Frame Long-term effect (6 months +) after intervention completion
Outcome Measure Data Not Reported
Time Frame Baseline to 180 days post randomization
Adverse Event Reporting Description Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
 
Arm/Group Title Docosahexaenoic Acid + Arachidonic Acid Placebo
Hide Arm/Group Description

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months

Corn oil supplement

Placebo: 400 mg corn oil per day for 6 months

All-Cause Mortality
Docosahexaenoic Acid + Arachidonic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/189 (0.00%)   0/188 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Docosahexaenoic Acid + Arachidonic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/189 (0.00%)   0/188 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Docosahexaenoic Acid + Arachidonic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   127/189 (67.20%)   129/188 (68.62%) 
Ear and labyrinth disorders     
ENT Symptoms   29/189 (15.34%)  33/188 (17.55%) 
Gastrointestinal disorders     
Gastrointestinal Symptoms   69/189 (36.51%)  63/188 (33.51%) 
Immune system disorders     
Misc Symptoms  [1]  35/189 (18.52%)  41/188 (21.81%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory symptoms   23/189 (12.17%)  22/188 (11.70%) 
Skin and subcutaneous tissue disorders     
Skin/Limb Symptoms   12/189 (6.35%)  18/188 (9.57%) 
Social circumstances     
Behavioral Symptoms  [2]  22/189 (11.64%)  19/188 (10.11%) 
Indicates events were collected by systematic assessment
[1]
Multi-symptom illnesses reported by caregivers which typically included more than 1 body system
[2]
Includes fussiness, temper tantrums, moodiness, etc.
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: Dr. Sarah Keim
Organization: Nationwide Children's Hospital
Phone: 614-722-3177
Responsible Party: Sarah Keim, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01576783     History of Changes
Other Study ID Numbers: 183210
First Submitted: April 10, 2012
First Posted: April 12, 2012
Results First Submitted: November 29, 2018
Results First Posted: May 24, 2019
Last Update Posted: May 24, 2019