Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study)
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|ClinicalTrials.gov Identifier: NCT03694314|
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : October 8, 2019
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|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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- Child behavior [ Time Frame: 3 months ]Will use the Child Behavior Checklist to evaluate changes in child behavior.
- Parental behavior [ Time Frame: 3 months ]Will use the Adult Self Report to evaluate changes in parent behavior.
- Child and parental cognitive behavior [ Time Frame: 3 months ]Will use online cognitive test to evaluate changes in cognition.
- Parental style [ Time Frame: 3 months ]Will use the Alabama Parenting questionnaire to evaluate changes in parenting style.
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|Ages Eligible for Study:||5 Years to 9 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- child between ages 5-9 with mother available to participate in intervention study
- intellectual disability
- significant psychiatric and physical illness
- extensive use of nutritional supplements within the past three months
- seafood allergy
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
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jianghong Liu, PhD||University of Pennsylvania|
|Responsible Party:||Jianghong Liu, Associate Professor, University of Pennsylvania|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Omega-3 fatty acids