NCT01985178

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 22, 2020

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

September 19, 2013

Last Update Submit

December 18, 2020

Conditions

Eating Disorder

Outcome Measures

Primary Outcomes (1)

  • Dropout rate

    2 months

Secondary Outcomes (2)

  • Rate of patients reporting side effects

    2 months

  • Change in weight

    2 months

Other Outcomes (1)

  • Severity of depressive symptoms

    2 months

Study Arms (1)

Omega-3 Fatty Acid Supplement

EXPERIMENTAL
Dietary Supplement: Omega-3 Fatty Acid Supplement

Interventions

Omega-3 Fatty Acid SupplementDIETARY_SUPPLEMENT
Omega-3 Fatty Acid Supplement

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • unable to read and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N3Z5, Canada

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Jennifer Couturier, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

November 15, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 22, 2020

Record last verified: 2015-04

Locations

CA(1)