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

Behavior Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694314
• Other study ID #: 829722
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

Inclusion Criteria:

• child between ages 5-9 with mother available to participate in intervention study

Exclusion Criteria:

• intellectual disability

• significant psychiatric and physical illness

• extensive use of nutritional supplements within the past three months

• seafood allergy

• diabetes

Related Conditions & MeSH terms

• Behavior Problem
• Disturbances in Initiating and Maintaining Sleep
• Problem Behavior

Intervention

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).
• Placebo
200 mL placebo fruit juice with no effect on the hypothesized outcome.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (2)

Liu J, Cui Y, Li L, Wu L, Hanlon A, Pinto-Martin J, Raine A, Hibbeln JR. The mediating role of sleep in the fish consumption - cognitive functioning relationship: a cohort study. Sci Rep. 2017 Dec 21;7(1):17961. doi: 10.1038/s41598-017-17520-w. — View Citation

Raine A, Portnoy J, Liu J, Mahoomed T, Hibbeln JR. Reduction in behavior problems with omega-3 supplementation in children aged 8-16 years: a randomized, double-blind, placebo-controlled, stratified, parallel-group trial. J Child Psychol Psychiatry. 2015 May;56(5):509-20. doi: 10.1111/jcpp.12314. Epub 2014 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep	For parent sleep patterns, we will use the Pittsburgh Sleep Quality Index to evaluate changes. For children's sleep, we will use the Child Sleep Habits questionnaire.	3 months
Secondary	Child behavior	Will use the Child Behavior Checklist to evaluate changes in child behavior.	3 months
Secondary	Parental behavior	Will use the Adult Self Report to evaluate changes in parent behavior.	3 months
Secondary	Child and parental cognitive behavior	Will use online cognitive test to evaluate changes in cognition.	3 months
Secondary	Parental style	Will use the Alabama Parenting questionnaire to evaluate changes in parenting style.	3 months