Clinical Trial: Treatment of Hypovitaminosis D in Rheumatoid Arthritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Hypovitaminosis D in Rheumatoid Arthritis

Brief Summary: This study recruits individuals with rheumatoid arthritis (RA) and low vitamin D concentrations. Subjects are dosed with vitamin D or placebo for one year. Primary outcome is change in bone turnover markers, additionally, bone mineral density and parameters of RA status are evaluated throughout the study.

Detailed Summary:

Osteoporosis is twice as common in people with rheumatoid arthritis (RA), compared to age and gender-matched controls [1, 2]. Hypovitaminosis D can contribute to osteoporosis pathogenesis by decreasing calcium absorption, leading to a decline in serum ionized calcium, a rise in parathyroid hormone levels and upregulation of osteoclast activity, leading to loss of calcium from the skeleton. Hypovitaminosis D is also common in patients with rheumatoid arthritis [3-5], making it an appealing target to potentially improve health in both RA and osteoporosis.

Vitamin D has theoretic potential to modulate RA disease activity, based on the presence of vitamin D receptors in lymphocytes, macrophages, chondrocytes, and synovial cells [6]. Vitamin D, given as the bioactive metabolite 1,25(OH)2D, ameliorates disease activity in murine models of RA [7, 8]. However, few studies have evaluated the effect of vitamin D on RA disease activity in humans. Two three month open-label studies reported that vitamin D reduced RA disease activity [9] and pain levels [10]. By contrast, an eight-week open-label study [11] reported no reduction in swollen joint counts, inflammatory markers or cytokine levels after vitamin D therapy. The only double-blind, placebo-controlled trial published thus far [12] found no significant effect of vitamin D on RA disease activity, but was limited by the lack of hypovitaminosis D as a criterion for study entry. Indeed, at baseline subjects' mean 25(OH)D levels indicated vitamin D repletion, potentially explaining the null effect of vitamin D on RA disease activity.

Three studies have evaluated the effect of vitamin D on bone mineral density (BMD) in patients with RA [13-15]. Researchers [14] randomized 96 subjects with RA to vitamin D (500 IU/day) and calcium (1000 mg/day) or placebo for two years; vitamin D and cal
Sponsor: University of Wisconsin, Madison

Current Primary Outcome: Parathyroid Hormone Level [ Time Frame: 1 Year ]

Serum parathyroid hormone level


Original Primary Outcome: Bone Turnover

Current Secondary Outcome:

  • Bone Mineral Density [ Time Frame: 1 Year ]
    one year change in mean total hip BMD
  • Short Form 36 Survey [ Time Frame: 1 Year ]
    12 month score for physical function domain of SF36 survey; scale 0 to 100 with 0 indicating worst disability and 100 indicating best physical function


Original Secondary Outcome:

  • Bone Mineral Density
  • SF-36


Information By: University of Wisconsin, Madison

Dates:
Date Received: January 17, 2007
Date Started: February 2005
Date Completion:
Last Updated: July 27, 2015
Last Verified: July 2015