Treatment of Hypovitaminosis D in Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT00423358|
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : August 24, 2015
Last Update Posted : August 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Hypovitaminosis D||Dietary Supplement: Vitamin D Dietary Supplement: placebo||Not Applicable|
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 . 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  and pain levels . By contrast, an eight-week open-label study  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  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  randomized 96 subjects with RA to vitamin D (500 IU/day) and calcium (1000 mg/day) or placebo for two years; vitamin D and calcium therapy modestly increased BMD in the spine and hip. In another study , 20 subjects randomized to daily calcium and 1 α-hydroxyvitamin D for up to 24 months experienced similar declines in radius and spine BMD compared to 15 controls . Likewise, vitamin D and calcium did not prevent bone loss in a prospective cohort study of patients with RA . However, none of the studies required hypovitaminosis D as an entry criterion, vitamin D repletion to 25(OH)D levels > 32 ng/ml were not evaluated [13, 14] or achieved , and low doses of vitamin D were administered, potentially limiting skeletal benefits of this therapy.
We hypothesized that correction of hypovitaminosis D in subjects with RA would decrease parathyroid hormone (PTH), increase BMD, improve functional capacity and down-regulate inflammatory cytokine production, thereby diminishing disease activity. Vitamin D is inexpensive and widely available. If proven beneficial, vitamin D might become a mainstay of therapy for subjects with RA.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Treatment of Hypovitaminosis D in Rheumatoid Arthritis|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||February 2009|
U.S. FDA Resources
Active Comparator: vitamin D
ergocalciferol 50,000 IU Twice monthly
Dietary Supplement: Vitamin D
Ergocalciferol 50,000 IU loading dose then twice monthly for one year
Other Name: ergocalciferol
Placebo Comparator: placebo
matching placebo tablet
Dietary Supplement: placebo
- Parathyroid Hormone Level [ Time Frame: 1 Year ]Serum parathyroid hormone level
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423358
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Karen E Hansen, MD||University of Wisconsin, Madison|