Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004420|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Rheumatoid Arthritis||Drug: gamma-Linolenic acid||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||September 1994|
|Study Completion Date :||August 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004420
|Study Chair:||Robert B. Zurier||University of Massachusetts, Worcester|