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Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

This study has been completed.
University of Massachusetts, Worcester
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: January 2000


I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.

Condition Intervention
Juvenile Rheumatoid Arthritis Drug: gamma-Linolenic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 50
Study Start Date: September 1994
Estimated Study Completion Date: August 1999
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.


Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

  • Juvenile rheumatoid arthritis (systemic onset, pauciarticular disease, and polyarticular disease)
  • Active synovitis

--Prior/Concurrent Therapy--

  • No more than 2 concurrent nonsteroidal antiinflammatory drugs
  • No more than 2 concurrent second line agents (e.g., D-penicillamine, oral or injectable gold, antimalarials, methotrexate, sulfasalazine)
  • Must have started second line agent at least 3 months prior to study
  • Must be on stable doses of all medications for at least 1 month prior to study
  • Prior prednisone allowed if started at least 3 months prior to study
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Please refer to this study by its identifier: NCT00004420

Sponsors and Collaborators
FDA Office of Orphan Products Development
University of Massachusetts, Worcester
Study Chair: Robert B. Zurier University of Massachusetts, Worcester
  More Information Identifier: NCT00004420     History of Changes
Other Study ID Numbers: 199/13314
Study First Received: October 18, 1999
Last Updated: March 24, 2015

Keywords provided by FDA Office of Orphan Products Development:
arthritis & connective tissue diseases
juvenile rheumatoid arthritis
rare disease

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents processed this record on August 18, 2017