Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT01426347
• Recruitment Status: Completed
• First Posted: August 31, 2011
• Results First Posted: March 20, 2017
• Last Update Posted: March 20, 2017
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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

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

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01426347
• 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; Vitamin D; Ergocalciferols; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents