Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
Not Applicable
Completed
- Conditions
- Juvenile Rheumatoid Arthritis
- Registration Number
- NCT00004420
- Lead Sponsor
- FDA Office of Orphan Products Development
- Brief Summary
OBJECTIVES:
I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
- Detailed Description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross over study of 12 months duration. Patients are stratified by type of juvenile rheumatoid arthritis (systemic onset vs pauciarticular disease vs polyarticular disease).
Patients are randomized to receive either gammalinolenic acid (GLA) or placebo (safflower seed oil) orally. Parents are asked to maintain the child's usual diet over the course of study.
Patients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method