Clinical trial
Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm
Name
00001037
Description
This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.
Trial arms
Trial start
2021-12-01
Estimated PCD
2024-06-30
Trial end
2024-12-31
Treatment
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
200 mg DHA+ 200 mg AA per day for 6 months
Arms:
Docosahexaenoic Acid + Arachidonic Acid
Placebo
400 mg corn oil per day for 6 months
Arms:
Placebo
Size
377
Primary endpoint
General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II)
A single study visit when the child is between 8.5 years to 10.5 years
Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth edition-CELF-5)
A single study visit when the child is between 8.5 years to 10.5 years
Executive Function (NIH Toolbox)
A single study visit when the child is between 8.5 years to 10.5 years
Eligibility criteria
Inclusion Criteria:
* Previous participation in Omega Tots (NCT01576783).
* Current age of 8 years, 180 days to 10 years, 180 days.
Exclusion Criteria:
* Child in custody of children's services for their window of eligibility
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 377, 'type': 'ESTIMATED'}}
Updated at
2023-12-20
1 organization
1 product
2 indications
Organization
Sarah KeimIndication
premature birthIndication
Child Development