Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin Therapy in Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Placebo sugar pill
* Drug: Ergocalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>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. | Drug: Placebo sugar pill<br>* Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.<br>* Other names: Placebo;Drug: Ergocalciferol<br>* Ergocalciferol 50,000 IU per week for 16 weeks<br>* Other names: Vitamin D;|
| Active Comparator: Ergocalciferol<br>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. | Drug: Ergocalciferol<br>* Ergocalciferol 50,000 IU per week for 16 weeks<br>* Other names: Vitamin D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score (DAS) 28 | 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). | Baseline and 16 weeks (end of Randomized Controlled Trial (RCT)) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Vitamin D deficiency, Disability