- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01985178
Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders
December 18, 2020 updated by: McMaster University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N3Z5
- McMaster Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of Eating Disorder, less than 18 years of age
Exclusion Criteria:
- unable to read and understand English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Omega-3 Fatty Acid Supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dropout rate
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients reporting side effects
Time Frame: 2 months
|
2 months
|
Change in weight
Time Frame: 2 months
|
2 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Severity of depressive symptoms
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (ACTUAL)
August 1, 2016
Study Completion (ACTUAL)
August 1, 2016
Study Registration Dates
First Submitted
September 19, 2013
First Submitted That Met QC Criteria
November 7, 2013
First Posted (ESTIMATE)
November 15, 2013
Study Record Updates
Last Update Posted (ACTUAL)
December 22, 2020
Last Update Submitted That Met QC Criteria
December 18, 2020
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12345 (Danish Center for Healthcare Improvements)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eating Disorder
-
University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersCompletedEating Disorder | Binge-eating DisorderUnited States
-
Sao Jose do Rio Preto Medical SchoolFundação de Amparo à Pesquisa do Estado de São PauloCompletedBinge-Eating Disorder | Eating Disorders | Eating Behavior | Eating Disorder | Binge Eating Disorder Associated With ObesityBrazil
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Lindner Center of HOPEUniversity of CincinnatiCompleted
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ShireCompleted
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Nova Scotia Health AuthorityCompletedBinge-Eating Disorder | Eating DisorderCanada
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University Hospital, MontpellierNot yet recruitingEating Disorders | Eating Disorder Binge
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Region of Southern DenmarkUniversity of Southern Denmark; JaschaFondenNot yet recruitingOther Specified Feeding or Eating Disorder | Eating Disorder NosDenmark
-
Nova Scotia Health AuthorityWithdrawnBulimia Nervosa | Eating Disorder | Binge Eating DisorderCanada
-
Drexel UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Yale...CompletedBinge-Eating Disorder | Weight Loss | Binge Eating | Eating DisorderUnited States
-
Marianne Lau, MD, DSci.The Ministry of Science, Technology and Innovation, DenmarkUnknownBulimia Nervosa (BN) | Binge Eating Disorder (BED) | Eating Disorder Not Otherwise Specified (EDNOS)Denmark
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-
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-
Icahn School of Medicine at Mount SinaiCompleted
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University of Michigan Rogel Cancer CenterCompleted
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Bangabandhu Sheikh Mujib Medical University, Dhaka...Recruiting
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Cedars-Sinai Medical CenterNational Institute of Mental Health (NIMH); Massachusetts General HospitalCompleted
-
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