Clinical trial NCT03694314: Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study)
Official title: Pilot Study on the Effects of Omega-3 Fatty Acid Supplements on Sleep and Behavior of Mother-child Pairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disturbances in Initiating and Maintaining Sleep
Behavior Problem
Keywords: Omega-3 fatty acids
Sleep
Behavior
Parenting
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Sleep
timeFrame: 3 months
Secondary outcomes:
measure: Child behavior
timeFrame: 3 months
measure: Parental behavior
timeFrame: 3 months
measure: Child and parental cognitive behavior
timeFrame: 3 months
measure: Parental style
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jianghong Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.