Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE August 29, 2011
First Posted Date  ICMJE August 31, 2011
Results First Submitted Date  ICMJE September 14, 2016
Results First Posted Date  ICMJE March 20, 2017
Last Update Posted Date March 20, 2017
Study Start Date  ICMJE January 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: August 30, 2011)
AIMS-SF [ Time Frame: 0, 3 and 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rheumatoid Arthritis
  • Vitamin D Deficiency
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2017)
139
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2011)
140
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01426347
Other Study ID Numbers  ICMJE VDRA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Uzma J Haque, M.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP