Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

Johns Hopkins University

Status: Completed

Conditions: Vitamin D Deficiency; Rheumatoid Arthritis

Treatments: Drug: Ergocalciferol; Drug: Placebo sugar pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01426347

VDRA

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR) criteria
• ages 18-75 years

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 tuberculosis (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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139 participants in 2 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo sugar pill

Drug: Ergocalciferol

Ergocalciferol

Active Comparator group

Description:

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.

Treatment:

Drug: Ergocalciferol