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Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01426347
First received: August 29, 2011
Last updated: January 27, 2017
Last verified: January 2017
  Purpose

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
Intervention Model: Parallel Assignment
Masking: Participant, 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:
  • 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:
  • 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.


Enrollment: 139
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426347

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     History of Changes
Other Study ID Numbers: VDRA
Study First Received: August 29, 2011
Results First Received: September 14, 2016
Last Updated: January 27, 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
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on March 27, 2017