Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Vitamin Therapy in Rheumatoid Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01426347
• Other study ID #: VDRA
• Status: Active, not recruiting
• Phase: N/A
• First received: August 29, 2011
• Last updated: August 30, 2011
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Vitamin D Deficiency

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AIMS-SF		0, 3 and 6 months	No
Secondary	Disease Activity Score 28		0, 3 and 6 months	No