Omega Tots: a Pilot Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital
First received: April 10, 2012
Last updated: April 26, 2013
Last verified: April 2013
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.
Dietary Supplement: Placebo
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Omega Tots: a Pilot Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Nationwide Children's Hospital:
Primary Outcome Measures:
- Enrollment and Trial Completion [ Time Frame: Pre-baseline to 180 days post-randomization ] [ Designated as safety issue: No ]The number of children who enroll in the trial and proportion who return for study visits 2 and 3.
- Adherence [ Time Frame: Baseline to 180 days post-randomization ] [ Designated as safety issue: No ]The proportion of children who adhere to the assigned supplement or placebo.
- Fatty Acid [ Time Frame: Baseline to 180 days post-randomization ] [ Designated as safety issue: No ]Change in plasma and RBC fatty acid concentrations from baseline to study visit 2.
Secondary Outcome Measures:
- Development [ Time Frame: Baseline to 180 days post-randomization ] [ Designated as safety issue: No ]Changes in Bayley Scales of Infant and Toddler Development - 3rd edition scores (cognitive, language, and motor sub-scales) from baseline to study visit 3.
Other Outcome Measures:
- Behavior [ Time Frame: Post-randomization ] [ Designated as safety issue: No ]Differences in temperament, social-emotional behavior, and sleep.
- Body Composition [ Time Frame: Baseline to 180 days post-randomization ] [ Designated as safety issue: No ]Changes in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds).
|Study Start Date:||April 2012|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: DHA arm
200 mg DHA + 200 mg AA per day, for 6 months
Placebo Comparator: Placebo
Corn oil supplement
Dietary Supplement: Placebo
400 mg corn oil per day for 6 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576783
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
Sponsors and Collaborators
|Principal Investigator:||Sarah Keim||Nationwide Children's Hospital|