Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT01426347 |
Recruitment Status :
Completed
First Posted : August 31, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis Vitamin D Deficiency | Drug: Placebo sugar pill Drug: Ergocalciferol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 139 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Vitamin Therapy in Rheumatoid Arthritis |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | January 2012 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: placebo group
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
Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
Other Name: Placebo Drug: Ergocalciferol Ergocalciferol 50,000 IU per week for 16 weeks
Other Name: Vitamin D |
Active Comparator: 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.
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Drug: Ergocalciferol
Ergocalciferol 50,000 IU per week for 16 weeks
Other Name: Vitamin D |
- Disease Activity Score (DAS) 28 [ Time Frame: 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).
- Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426347
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Uzma J Haque, M.D. | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01426347 |
Other Study ID Numbers: |
VDRA |
First Posted: | August 31, 2011 Key Record Dates |
Results First Posted: | March 20, 2017 |
Last Update Posted: | March 20, 2017 |
Last Verified: | January 2017 |
Rheumatoid Arthritis Vitamin D deficiency Disability |
Arthritis Arthritis, Rheumatoid Vitamin D Deficiency Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Avitaminosis Deficiency Diseases |
Malnutrition Nutrition Disorders Vitamin D Ergocalciferols Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |