- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01576783
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
June 9, 2021 updated by: Sarah Keim
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
377
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 months to 1 year (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 10-16 completed months (age corrected for prematurity) at baseline
- Discontinued regular breastfeeding and formula feeding at the time of randomization
- Gestational age < 35 completed weeks at birth
- English is primary language in home
- Informed consent obtained and signed
- Child admitted to any NCH managed NICU or children who have ever had a Neonatology Clinic follow up visit scheduled, regardless of attendance
Exclusion Criteria:
- Feeding problems
- Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.
- Weight < 5th or > 95th percentile for age, per WHO growth charts
- Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week
- Plans to move out of the area within the next 6 months
- Known corn allergy
- Known soy allergy
- Known fish allergy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docosahexaenoic Acid + Arachidonic Acid
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
|
200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo Comparator: Placebo
Corn oil supplement
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400 mg corn oil per day for 6 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythrocyte Fatty Acid Levels
Time Frame: Baseline to 180 days post-randomization
|
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
|
Baseline to 180 days post-randomization
|
Erythrocyte Fatty Acid Levels (Additional Data)
Time Frame: Baseline to 180 days post-randomization
|
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
|
Baseline to 180 days post-randomization
|
Enrollment and Trial Completion
Time Frame: Baseline to 180 days post-randomization
|
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.
|
Baseline to 180 days post-randomization
|
Adherence
Time Frame: Baseline to 180 days post-randomization
|
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
|
Baseline to 180 days post-randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)
Time Frame: Baseline to 180 days post-randomization
|
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).
|
Baseline to 180 days post-randomization
|
(Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)
Time Frame: Baseline to 180 days post-randomization
|
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
|
Baseline to 180 days post-randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Infant Sleep Questionnaire (BISQ)
Time Frame: Baseline to 180 days post-randomization
|
The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours).
Larger values represent more time spent in each type of sleep.
BISQ 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 BISQ value at 180 days minus the BISQ value at baseline).
|
Baseline to 180 days post-randomization
|
Body Composition
Time Frame: Baseline to 180 days post-randomization
|
Changes in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds).
These measurements were converted to z scores for corrected age based on Child Growth Standards from the World Health Organization.
The z-score indicates the number of standard deviations away from the mean.
A z score of 0 is equal to the mean of a reference population (children the same age and sex).
Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate values higher than the reference population.
|
Baseline to 180 days post-randomization
|
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Time Frame: 180 days post-randomization
|
BITSEA measures socioemotional development in toddlerhood.
Scores were summed to provide competence (range: 0-22) and problem (range: 0-62) scores, respectively.
The problem scale is further divided into subscales: externalizing (6 items; range: 0-12), internalizing (8 items; range: 0-16), and dysregulation (8 items; range: 0-16).
Additionally, 14 items comprise a red flag scale (range: 0-28).
Eight items from the competence and nine items from the problem subscales are indicative of behaviors often seen in children with ASD.
Each of the 17 ASD items was dichotomized to illustrate the presence (1) (i.e., competence items absent, problem items present) or absence (0) (i.e., competence items present, problem items absent) of each ASD behavior.
Items were then summed to derive an ASD score (range: 0-17).
Higher competence scores represent better functioning, whereas higher problem (including the problem subscales), red flag, and ASD scores were indicative of poorer functioning.
|
180 days post-randomization
|
Pervasive Developmental Disorders Screening Test - II, Stage 2 (PDDST-II)
Time Frame: 180 days post-randomization
|
The PDDST-II is a clinically derived, caregiver-completed screener to assist in differentiating an ASD diagnosis from other disorders in children with developmental concerns, including those born preterm.
The PDDST-II comprised 14 yes/no items that indicate the presence (1) or absence (0) of developmental concerns.
Items were summed (possible range: 0-14) and higher scores represented greater developmental concern.
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180 days post-randomization
|
Other Long-term Outcomes: Sleep (BISQ)
Time Frame: Long-term effect (approximately 8 months) after intervention completion
|
Long-term (26-32 months of age) outcomes.
This will be evaluated using scores on the Brief Infant Sleep Questionnaire (BISQ).The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours).
Larger values represent more time spent in each type of sleep.
BISQ scores were measured at baseline and then again at post-intervention follow-up (approximately 8 months after the trial ended).
The scores were calculated as a change between two time points (the BISQ value at post-intervention follow-up minus the BISQ value at baseline).
|
Long-term effect (approximately 8 months) after intervention completion
|
Other Long-term Outcomes: Sleep (CSHQ)
Time Frame: Long-term effect (approximately 8 months) after intervention completion
|
Long-term (26-32 months of age) outcomes.
This will be evaluated using the total score on a subset of 13 items from the Children's Sleep Habits Questionnaire (CSHQ).
The range in total score is 13-39.
A higher score is indicative of more sleep problems.
|
Long-term effect (approximately 8 months) after intervention completion
|
Long-term Efficacy in Improving Cognition
Time Frame: Long-term effect (approximately 8 months) after intervention completion
|
Long-term (26-32 months of age) cognitive outcome.
This will be evaluated based on standard scores from the cognitive section of the Developmental Profile - 3. The range in standard scores is 40-140 with higher scores represent better cognitive ability.
|
Long-term effect (approximately 8 months) after intervention completion
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Time Frame: Long-term effect (approximately 8 months) after intervention completion
|
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).
The BRIEF-P yields five clinical scales, each measuring a different aspect of executive function: inhibit, shift, emotional control, working memory, and plan/organize.
The clinical scales merge to create four broad indices of executive function: inhibitory self-control, flexibility, emergent metacognition, and global executive composite.
A t-score of 50 is equal to the population mean with scores below 50 indicating better executive function, and scores above 50 indicating worse executive function for each reported aspect.
|
Long-term effect (approximately 8 months) after intervention completion
|
Long-term Efficacy in Improving Executive Functions (CBCL)
Time Frame: Long-term effect (approximately 8 months) after intervention completion
|
Long-term (26-32 months of age) executive function outcomes.
This will be evaluated using scores on the Attention Deficit/Hyperactivity Problems DSM oriented subscale and the Attention syndrome subscale of the Child Behavior Checklist 1.5-5 (CBCL).
A t-score of 50 is equal to the population mean with scores below 50 indicating less behavioral problems, and scores above 50 indicating more behavioral problems.
|
Long-term effect (approximately 8 months) after intervention completion
|
Other Long-term Outcomes: Pervasive Developmental Problems
Time Frame: Long-term effect (approximately 8 months) after intervention completion
|
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).
A t-score of 50 is equal to the population mean with scores below 50 indicating less problems and scores above 50 indicating more problems.
|
Long-term effect (approximately 8 months) after intervention completion
|
Other Long-term Outcomes: Language
Time Frame: Long-term effect (approximately 8 months) after intervention completion
|
Long-term (26-32 months of age) outcomes.
This will be evaluated using scores on the Communicative Development Inventory (CDI).
On this measure, caregivers selected the number of words from a list of 100 common words that their child used.
Scores reflect the total number of words, from the list of 100, that the child used.
|
Long-term effect (approximately 8 months) after intervention completion
|
Other Long-term Outcomes: Number of Participants With Developmental Delay
Time Frame: Long-term effect (approximately 8 months) after intervention completion
|
Long-term (26-32 months of age) outcomes.
This will be evaluated using caregiver reports/diagnoses of developmental delay.
|
Long-term effect (approximately 8 months) after intervention completion
|
Other Long-term Outcomes: Number of Participants With Behavior Difficulties
Time Frame: Long-term effect (approximately 8 months) after intervention completion
|
Long-term (26-32 months of age) outcomes.
This will be evaluated using caregiver reports/diagnoses of behavioral difficulties.
|
Long-term effect (approximately 8 months) after intervention completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Boone KM, Pattison K, Pelak G, Sheppard KW, Rausch J, Yeates KO, Nelin MA, Klebanoff MA, Turner AN, Rogers LK, Keim SA. Docosahexaenoic and arachidonic acid supplementation at 1 year has mixed effects on development and behaviour at age 2 for preterm children. Acta Paediatr. 2021 Jul;110(7):2082-2083. doi: 10.1111/apa.15858. Epub 2021 Apr 12. No abstract available.
- Sullivan JA, Wiese AM, Boone KM, Rausch J, Keim SA. To attend, or not to attend: Examining caregiver intentions and study compliance in a pediatric, randomized controlled trial. Clin Trials. 2020 Apr;17(2):223-230. doi: 10.1177/1740774519893307. Epub 2020 Jan 27.
- Boone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep in Toddlers Born Preterm: Secondary Analysis of a Randomized Clinical Trial. J Clin Sleep Med. 2019 Sep 15;15(9):1197-1208. doi: 10.5664/jcsm.7902.
- Boone KM, Nelin MA, Chisolm DJ, Keim SA. Gaps and Factors Related to Receipt of Care within a Medical Home for Toddlers Born Preterm. J Pediatr. 2019 Apr;207:161-168.e1. doi: 10.1016/j.jpeds.2018.10.065. Epub 2018 Dec 19. Erratum In: J Pediatr. 2019 Dec;215:289.
- Keim SA, Boone KM, Klebanoff MA, Turner AN, Rausch J, Nelin MA, Rogers LK, Yeates KO, Nelin L, Sheppard KW. Effect of Docosahexaenoic Acid Supplementation vs Placebo on Developmental Outcomes of Toddlers Born Preterm: A Randomized Clinical Trial. JAMA Pediatr. 2018 Dec 1;172(12):1126-1134. doi: 10.1001/jamapediatrics.2018.3082. Erratum In: JAMA Pediatr. 2019 Dec 1;173(12):1215.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2012
Primary Completion (Actual)
April 6, 2017
Study Completion (Actual)
April 6, 2017
Study Registration Dates
First Submitted
April 10, 2012
First Submitted That Met QC Criteria
April 11, 2012
First Posted (Estimate)
April 12, 2012
Study Record Updates
Last Update Posted (Actual)
June 29, 2021
Last Update Submitted That Met QC Criteria
June 9, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 183210
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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