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

University of Pennsylvania

Status: Completed

Conditions: Behavior Problem; Disturbances in Initiating and Maintaining Sleep

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Omega-3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT03694314

829722

Details and patient eligibility

About

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.

Full 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).

Enrollment: 29 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

29 participants in 2 patient groups, including a placebo group

Omega-3 fatty acids

Experimental group

Description:

Both the mother and child will receive omega-3 supplements in the form of a 200 mL drink to be taken once daily. The intervention will last 45 days. Assessments will take place at 0 months (baseline), 45 days (end of treatment), and 3 months (1 and a half months post-treatment).

Treatment:

Dietary Supplement: Omega-3 fatty acids

Placebo

Placebo Comparator group

Description:

The mother and child will both receive a placebo drink to take daily, with no known effect on the brain. The intervention will last 45 days. Assessments will take place at 0 months (baseline), 45 days (end of treatment), and 3 months (1 and a half months post-treatment).

Treatment:

Dietary Supplement: Placebo