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

Tracking Information

• First Submitted Date: August 29, 2011
• First Posted Date: August 31, 2011
• Results First Submitted Date: September 14, 2016
• Results First Posted Date: March 20, 2017
• Last Update Posted Date: March 20, 2017
• Study Start Date: January 2009
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 27, 2017)

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).

• Original Primary Outcome Measures (submitted: August 30, 2011): AIMS-SF [ Time Frame: 0, 3 and 6 months ]

Current Secondary Outcome Measures (submitted: January 27, 2017)

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.

• Original Secondary Outcome Measures (submitted: August 30, 2011): Disease Activity Score 28 [ Time Frame: 0, 3 and 6 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
• Official Title: Vitamin Therapy in Rheumatoid Arthritis

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Rheumatoid Arthritis
• Vitamin D Deficiency

Intervention

• 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

Study Arms

• 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.

  Interventions:

  • Drug: Placebo sugar pill
  • Drug: Ergocalciferol
• 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.
  Intervention: Drug: Ergocalciferol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 27, 2017): 139
• Original Estimated Enrollment (submitted: August 30, 2011): 140
• Actual Study Completion Date: January 2012
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01426347
• Other Study ID Numbers: VDRA
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Johns Hopkins University
• Study Sponsor: Johns Hopkins University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Johns Hopkins University
• Verification Date: January 2017