Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo sugar pill	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 group	Ergocalciferol	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.
Ergocalciferol	Ergocalciferol	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.

Primary Outcome Measures

Name	Time	Method
Disease Activity Score (DAS) 28	Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))	We measured disease activity as measured by DAS 28 at baseline and at the completion of Randomized Controlled trial, both in the placebo and the active treatment group. We used DAS-28 scores to indicate disease activity. The DAS -28 scale has a minimum of 0 and a maximum of 10, with higher numbers indicating higher disease activity. We used the following cut-offs: Remission (\< 2.6), low disease activity (\< 3.2), moderate disease activity (\< 5.1) and high disease activity (\> 5.1).

Secondary Outcome Measures

Name	Time	Method
Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)	Baseline and 16 weeks (end of RCT)	In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.