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

NCT03694314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-10-08

No results posted yet for this study

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.

Conditions

  • Disturbances in Initiating and Maintaining Sleep
  • Behavior Problem

Interventions

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).

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Jianghong Liu, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694314 on ClinicalTrials.gov