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

Primary Purpose

Disturbances in Initiating and Maintaining Sleep, Behavior Problem

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acids
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disturbances in Initiating and Maintaining Sleep focused on measuring Omega-3 fatty acids, Sleep, Behavior, Parenting

Eligibility Criteria

5 Years - 9 Years (Child)All SexesAccepts 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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3 fatty acids

Placebo

Arm 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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Child behavior
Will use the Child Behavior Checklist to evaluate changes in child behavior.
Parental behavior
Will use the Adult Self Report to evaluate changes in parent behavior.
Child and parental cognitive behavior
Will use online cognitive test to evaluate changes in cognition.
Parental style
Will use the Alabama Parenting questionnaire to evaluate changes in parenting style.

Full Information

First Posted
July 30, 2018
Last Updated
October 5, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03694314
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disturbances in Initiating and Maintaining Sleep, Behavior Problem
Keywords
Omega-3 fatty acids, Sleep, Behavior, Parenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 fatty acids
Arm Type
Experimental
Arm 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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
200 mL placebo fruit juice with no effect on the hypothesized outcome.
Primary Outcome Measure Information:
Title
Sleep
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Child behavior
Description
Will use the Child Behavior Checklist to evaluate changes in child behavior.
Time Frame
3 months
Title
Parental behavior
Description
Will use the Adult Self Report to evaluate changes in parent behavior.
Time Frame
3 months
Title
Child and parental cognitive behavior
Description
Will use online cognitive test to evaluate changes in cognition.
Time Frame
3 months
Title
Parental style
Description
Will use the Alabama Parenting questionnaire to evaluate changes in parenting style.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianghong Liu, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25146492
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.
Results Reference
background
PubMed Identifier
29269884
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.
Results Reference
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Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study)

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