NCT03694314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

July 30, 2018

Last Update Submit

October 5, 2019

Conditions

Disturbances in Initiating and Maintaining SleepBehavior Problem

Keywords

Omega-3 fatty acidsSleepBehaviorParenting

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (4)

  • Child behavior

    3 months

  • Parental behavior

    3 months

  • Child and parental cognitive behavior

    3 months

  • Parental style

    3 months

Study Arms (2)

Omega-3 fatty acids

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Omega-3 fatty acidsDIETARY_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).

Omega-3 fatty acids
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • child between ages 5-9 with mother available to participate in intervention study

You may not qualify if:

  • intellectual disability
  • significant psychiatric and physical illness
  • extensive use of nutritional supplements within the past three months
  • seafood allergy
  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 25146492BACKGROUND

  • 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.

    PMID: 29269884BACKGROUND

MeSH Terms

Conditions

Mental DisordersBehavior

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Jianghong Liu, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 30, 2018

First Posted

October 3, 2018

Study Start

May 15, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)