NCT00004420

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 1994

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1994

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2000

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Juvenile Rheumatoid Arthritis

Keywords

arthritis & connective tissue diseasesjuvenile rheumatoid arthritisrare disease

Interventions

gamma-Linolenic acidDRUG

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
PROTOCOL ENTRY CRITERIA: --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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, JuvenileArthritisConnective Tissue DiseasesRare Diseases

Interventions

gamma-Linolenic Acid

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Linolenic AcidsFatty Acids, EssentialFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, Omega-6

Study Officials

  • Robert B. Zurier

    University of Massachusetts, Worcester

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

September 1, 1994

Study Completion

August 1, 1999

Last Updated

March 25, 2015

Record last verified: 2000-01