Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Study Start Date:||September 1994|
|Estimated Study Completion Date:||August 1999|
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.
|Study Chair:||Robert B. Zurier||University of Massachusetts, Worcester|