Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Uzma Haque, Johns Hopkins University Identifier:
First received: August 29, 2011
Last updated: August 30, 2011
Last verified: August 2011

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 Intervention
Rheumatoid Arthritis
Vitamin D Deficiency
Drug: Placebo sugar pill
Drug: Ergocalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin Therapy in Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • AIMS-SF [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease Activity Score 28 [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01426347

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Uzma J Haque, M.D. Johns Hopkins University
  More Information

Responsible Party: Uzma Haque, Assistant Professor of Medicine, Johns Hopkins University Identifier: NCT01426347     History of Changes
Other Study ID Numbers: VDRA 
Study First Received: August 29, 2011
Last Updated: August 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Rheumatoid Arthritis
Vitamin D deficiency

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Vitamin D Deficiency
Autoimmune Diseases
Connective Tissue Diseases
Deficiency Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Nutrition Disorders
Rheumatic Diseases
Vitamin D
Bone Density Conservation Agents
Growth Substances
Physiological Effects of Drugs processed this record on May 23, 2016