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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03694314
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : October 8, 2019
Information provided by (Responsible Party):
Jianghong Liu, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Disturbances in Initiating and Maintaining Sleep Behavior Problem Dietary Supplement: Omega-3 fatty acids Dietary Supplement: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study on the Effects of Omega-3 Fatty Acid Supplements on Sleep and Behavior of Mother-child Pairs
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Omega-3 fatty acids
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).
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 Comparator: Placebo
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).
Dietary Supplement: Placebo
200 mL placebo fruit juice with no effect on the hypothesized outcome.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694314

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Jianghong Liu, PhD University of Pennsylvania
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Responsible Party: Jianghong Liu, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03694314    
Other Study ID Numbers: 829722
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianghong Liu, University of Pennsylvania:
Omega-3 fatty acids
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms