Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis; Vitamin D Deficiency	Drug: Placebo sugar pill; Drug: Ergocalciferol	Not Applicable

Study Design

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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

Arms and Interventions

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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.	Drug: Ergocalciferol; Ergocalciferol 50,000 IU per week for 16 weeks; Other Name: Vitamin D

Outcome Measures

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Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:	Uzma J Haque, M.D.	Johns Hopkins University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01426347 History of Changes
Other Study ID Numbers:	VDRA
First Posted:	August 31, 2011
Results First Posted:	March 20, 2017
Last Update Posted:	March 20, 2017
Last Verified:	January 2017

Keywords provided by Johns Hopkins University:

Rheumatoid Arthritis; Vitamin D deficiency; Disability

Additional relevant MeSH terms:

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; Vitamins; Vitamin D; Ergocalciferols; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents