Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
---|---|
Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00094562 |
The purpose of this study is to evaluate the safety and effectiveness of fish oil supplements in maintaining weight in people with disease-related weight loss and/or cachexia.
Condition | Intervention | Phase |
---|---|---|
Cancer Cancer Cachexia Chronic Obstructive Pulmonary Disease Chronic Heart Failure Rheumatoid Arthritis |
Drug: Fish oil supplement |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss |
Estimated Enrollment: | 60 |
Study Start Date: | June 2004 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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:
Goals of the Study:
Study Outline:
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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | P50 AT000437, JHM - IRB # 03-02-10-12 |
Study First Received: | October 20, 2004 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00094562 History of Changes |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Cancer Cancer Cachexia Weight Loss |
Chronic Obstructive Pulmonary Disease Chronic Heart Failure Rheumatoid Arthritis |
Heart Failure Heart Diseases Autoimmune Diseases Joint Diseases Respiration Disorders Benzocaine Arthritis, Rheumatoid Cachexia Emaciation Rheumatic Diseases Body Weight |
Signs and Symptoms Lung Diseases, Obstructive Respiratory Tract Diseases Musculoskeletal Diseases Arthritis Lung Diseases Weight Loss Body Weight Changes Connective Tissue Diseases Pulmonary Disease, Chronic Obstructive |
Heart Failure Heart Diseases Autoimmune Diseases Immune System Diseases Joint Diseases Respiration Disorders Arthritis, Rheumatoid Cachexia Emaciation Rheumatic Diseases Body Weight |
Signs and Symptoms Lung Diseases, Obstructive Respiratory Tract Diseases Musculoskeletal Diseases Arthritis Lung Diseases Weight Loss Body Weight Changes Connective Tissue Diseases Cardiovascular Diseases Pulmonary Disease, Chronic Obstructive |