N/A N=83 Randomized Triple-blind Treatment

Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis · Vitamin D Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT01426347 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Disease Activity Score (DAS) 28 — 3.4; 2.8; 3.5; 3.1 composite score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Placebo sugar pill (Drug); Ergocalciferol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Disease Activity Score (DAS) 28	3.4; 2.8; 3.5; 3.1	—
SECONDARY Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)	1.9; 1.7; 1.9; 1.6	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT01426347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.