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Completed

NCT Number: NCT03694314

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

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.

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Key information

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Sleep

    Time frame: 3 months

    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.

Secondary outcomes

  1. Child behavior

    Time frame: 3 months

    Will use the Child Behavior Checklist to evaluate changes in child behavior.

  2. Parental behavior

    Time frame: 3 months

    Will use the Adult Self Report to evaluate changes in parent behavior.

  3. Child and parental cognitive behavior

    Time frame: 3 months

    Will use online cognitive test to evaluate changes in cognition.

  4. Parental style

    Time frame: 3 months

    Will use the Alabama Parenting questionnaire to evaluate changes in parenting style.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2018
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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