Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
NCT ID: NCT01426347
Last Updated: 2017-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2009-01-31
2012-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Placebo sugar pill
Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
Ergocalciferol
Ergocalciferol 50,000 IU per week for 16 weeks
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.
Ergocalciferol
Ergocalciferol 50,000 IU per week for 16 weeks
Interventions
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Placebo sugar pill
Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
Ergocalciferol
Ergocalciferol 50,000 IU per week for 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ages 18-75 years
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Uzma J Haque, M.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Countries
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Other Identifiers
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VDRA
Identifier Type: -
Identifier Source: org_study_id
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