A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
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|ClinicalTrials.gov Identifier: NCT00094562|
Recruitment Status : Completed
First Posted : October 21, 2004
Last Update Posted : April 22, 2008
|Condition or disease||Intervention/treatment||Phase|
|Cancer Cancer Cachexia Chronic Obstructive Pulmonary Disease Chronic Heart Failure Rheumatoid Arthritis||Drug: Fish oil supplement||Phase 2|
The overall goal of this project is to evaluate the safety and efficacy of nutritional supplementation with fish oils to maintain weight in patients with disease-related weight loss (cachexia). Weight loss commonly results in a poorer prognosis, functional status, and quality of life. Despite the high morbidity and mortality associated with cachexia, mainstream treatment does not sustain weight and although nutritional supplements are commonly used, many of these have not been tested in clinical trials. Recent work in cachexia has revealed that this is mediated by pro-inflammatory cytokines. There are data that suggests that fish oils can affect the underlying pathogenic inflammatory response and have an affect on weight maintenance and nutritional balance
Diseases in which cachexia is most common:
- Chronic Heart Failure (CHF)
- Chronic Obstructive Pulmonary Disease (COPD)
- Rheumatoid Arthritis (RA)
Goals of the Study:
- To evaluate the safety and efficacy of fish oils vs. corn oil in the maintenance of weight and lean body mass in patients with disease-related weight loss.
- To understand the mechanism of fish oil effect on health maintenance by evaluating the anti-inflammatory, anti-catabolic, anti-oxidant and anabolic actions of these compounds
- To document the effect of our interventions on quality of life and functional status.
Participants will be randomly assigned to receive either fish oil supplements or corn oil for the duration of this 3-month study. Participants will have five study visits and two telephone interviews. During each study visit, participants will undergo laboratory tests, a physical exam, and a dual energy X-ray absorptiometry (DEXA) bone scan. Participants will be asked to keep a food diary during the study. During the telephone interviews, participants will be asked health-related questions and discuss their current functional status.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
- Body weight
- lean body mass
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): NCT00094562
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Adrian S. Dobs, MD, MHS||Johns Hopkins University|