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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
139
Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
Ergocalciferol 50,000 IU per week for 16 weeks
Johns Hopkins University
Baltimore, Maryland, United States
Disease Activity Score (DAS) 28
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).
Time frame: Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))
Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)
In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.
Time frame: Baseline and 16 weeks (end of RCT)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.