Trials / Completed
CompletedNCT00004420
Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (planned)
- Sponsor
- FDA Office of Orphan Products Development · Federal
- Sex
- All
- Age
- 1 Year – 15 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gamma-Linolenic acid |
Timeline
- Start date
- 1994-09-01
- Completion
- 1999-08-01
- First posted
- 1999-10-19
- Last updated
- 2015-03-25
Source: ClinicalTrials.gov record NCT00004420. Inclusion in this directory is not an endorsement.