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Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Uzma Haque, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01426347
First received: August 29, 2011
Last updated: August 30, 2011
Last verified: August 2011
History of Changes

August 29, 2011
August 30, 2011
January 2009
December 2011   (final data collection date for primary outcome measure)
AIMS-SF [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01426347 on ClinicalTrials.gov Archive Site
Disease Activity Score 28 [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
Vitamin Therapy in Rheumatoid Arthritis

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Vitamin D Deficiency
  • 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
  • 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.

    Intervention: Drug: Placebo sugar pill
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Rheumatoid Arthritis diagnosed according to ACR criteria
  • ages 18-75

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 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01426347
VDRA
No
Uzma Haque, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Uzma J Haque, M.D. Johns Hopkins University
Johns Hopkins University
August 2011

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