NCT03694314

Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study)

Pilot Study on the Effects of Omega-3 Fatty Acid Supplements on Sleep and Behavior of Mother-child Pairs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Accepted

Summary

The aim of this feasibility study is to determine whether a nutritional intervention in children and their parents can improve their sleep quality and behavior. The study is a randomized, double-blind, placebo-controlled parallel trial of omega-3 supplementation to children and their mothers.

Detailed description

Previous studies show omega-3 fatty acid supplements improve adolescent's antisocial behavior. However it is less known whether the same effect could be achieved in younger children. Furthermore it is not known whether omega-3 fatty acids could also improve parental behavior and parenting style which could further reduce behavioral problems in children. Moreover, we recently found that children who consume fish more frequently have less sleep problems but it is not known whether omega-3 supplements could also potentially improve children's sleep. We aim to test several hypotheses in this random controlled trial of omega-3 fatty acids. The study design will consist of a double-blind, randomized placebo-controlled trial of children and their caregivers in a community sample in the city of Philadelphia. It will utilize a random parallel design, in which child and mother pairs will be randomly assigned to either omega-3 supplementation (treatment condition) or a placebo (control condition). This results in 2 groups: (1) child and caregiver both receiving omega-3 and (2) both parent and child receiving the placebo. Treatment will last 45 days. Assessments will take place at 0 months (baseline), 45 days (end of supplementation) and 90 days (45 days after the end of treatment).

Conditions

• Disturbances in Initiating and Maintaining Sleep
• Behavior Problem

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3 fatty acids	200 ml drink. The drink contains 840 mg total of omega-3 (360 mg of DHA, 240 mg of EPA, 200 mg of alpha-linolenic acid, and 40 mg of DPA).
DIETARY_SUPPLEMENT	Placebo	200 mL placebo fruit juice with no effect on the hypothesized outcome.

Timeline

• Start date: 2018-05-15
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2018-10-03
• Last updated: 2019-10-08

Locations

1 site across 1 country: United States