Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, vitamin d deficiency
Treatments placebo sugar pill, ergocalciferol
Sponsor Johns Hopkins University
Start date January 2009
End date December 2011
Trial size 140 participants
Trial identifier NCT01426347, VDRA

Summary

The purpose of this study is to investigate the effect of vitamin D repletion on disease activity and disability in patients with rheumatoid arthritis.

The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D deficiency have greater disease activity and disability, compared to RA patients with normal vitamin D levels. The investigators also hypothesize that vitamin D treatment in these deficient patients will result in a decrease in RA disease activity and disability.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms. Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.
placebo sugar pill Placebo
Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
(Active Comparator)
Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.
ergocalciferol Vitamin D
Ergocalciferol 50,000 IU per week for 16 weeks

Primary Outcomes

Measure
AIMS-SF
time frame: 0, 3 and 6 months

Secondary Outcomes

Measure
Disease Activity Score 28
time frame: 0, 3 and 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Rheumatoid Arthritis diagnosed according to ACR criteria - ages 18-75 Exclusion Criteria: - Diagnosis of any other autoimmune disease: such as Lupus, Scleroderma, Myositis, Sjogren's Syndrome, Vasculitis' - Having any of the following conditions with in the last 6 months Hypercalcemia, Hyperparathyroidism, Active TB, Lymphoma or any other type of cancer, Sarcoidosis, Seizure, Stroke - Severe heart problems - Kidney failure requiring dialysis treatment - Liver failure or cirrhosis of the liver - Poorly controlled hypertension - current uncontrolled Depression, Bipolar Disorder, or other Psychiatric illness - Pregnancy

Additional Information

Official title Vitamin Therapy in Rheumatoid Arthritis
Principal investigator Uzma J Haque, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Johns Hopkins University.