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Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders

Primary Purpose

Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Omega-3 Fatty Acid Supplement
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of Eating Disorder, less than 18 years of age

Exclusion Criteria:

  • unable to read and understand English

Sites / Locations

  • McMaster Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega-3 Fatty Acid Supplement

Arm Description

Outcomes

Primary Outcome Measures

Dropout rate

Secondary Outcome Measures

Rate of patients reporting side effects
Change in weight

Full Information

First Posted
September 19, 2013
Last Updated
December 18, 2020
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01985178
Brief Title
Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders
Official Title
Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Eating disorders are conditions that are defined by abnormal eating habits that involve insufficient or excessive food intake. With regards to treating these disorders, there is an increasing interest in fat deprivation due to a lack of proper diet, particularly dietary fats such as polyunsaturated fatty acids. These fatty acids are essential components of the brain and are important for normal functioning of the body. Since the body cannot synthesize these fats, it has to rely completely on diet to obtain a sufficient amount. Hence, diets that lack sufficient fats or under fasting conditions, the imbalance of these fats can severely alter brain functions. The investigators want to see if these supplements are well tolerated and accepted by adolescent patients with eating disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 Fatty Acid Supplement
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty Acid Supplement
Primary Outcome Measure Information:
Title
Dropout rate
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Rate of patients reporting side effects
Time Frame
2 months
Title
Change in weight
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Severity of depressive symptoms
Time Frame
2 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of Eating Disorder, less than 18 years of age Exclusion Criteria: unable to read and understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Couturier, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada

12. IPD Sharing Statement

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Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders

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