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CompletedNCT00423358Updated Aug 24, 2015Results posted

Treatment of Hypovitaminosis D in Rheumatoid Arthritis

An interventional study of Vitamin D and placebo in Rheumatoid Arthritis and Hypovitaminosis D, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-08-24.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

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 calcium therapy modestly increased BMD in the spine and hip. In another study [15], 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 [15]. Likewise, vitamin D and calcium did not prevent bone loss in a prospective cohort study of patients with RA [13]. 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 [15], 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.

02

Conditions studied

  • Rheumatoid Arthritis
  • Hypovitaminosis D

Keywords

  • rheumatoid arthritis
  • hypovitaminosis D
  • bone turnover
  • ergocalciferol
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 22 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Rheumatology

Exclusion criteria

Exclusion Criteria:

  • Bisphosphonate therapy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • Active comparator
    vitamin D

    ergocalciferol 50,000 IU Twice monthly

    Dietary Supplement: Vitamin D

  • Placebo comparator
    placebo

    matching placebo tablet

    Dietary Supplement: placebo

Interventions

  • Dietary supplementVitamin D

    Ergocalciferol 50,000 IU loading dose then twice monthly for one year

    Also known as: ergocalciferol

  • Dietary supplementplacebo

    matching placebo

06

What researchers measure

Primary outcomes

  1. Parathyroid Hormone Level

    Serum parathyroid hormone level

    Time frame: 1 Year

Secondary outcomes

  1. Bone Mineral Density

    one year change in mean total hip BMD

    Time frame: 1 Year

  2. Short Form 36 Survey

    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

    Time frame: 1 Year

07

Results

Posted Aug 24, 2015

Participant flow

Participant flow — Overall Study
MilestoneVitamin DPlacebo
Started1111
Completed1111
Not completed00

Outcome measures

PrimaryParathyroid Hormone Level

Serum parathyroid hormone level

Time frame:
1 Year
Reported as:
Mean · pg/mL
Parathyroid Hormone Level
pg/mLVitamin D, n=11Placebo, n=11
Parathyroid Hormone Level19 ± 1120 ± 11
SecondaryBone Mineral Density

one year change in mean total hip BMD

Time frame:
1 Year
Reported as:
Mean · g/cm2
Bone Mineral Density
g/cm2Vitamin D, n=11Placebo, n=11
Bone Mineral Density0.970 ± 0.1401.151 ± 0.168
SecondaryShort Form 36 Survey

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

Time frame:
1 Year
Reported as:
Mean · units from 0 (worst) to 100 (best)
Short Form 36 Survey
units from 0 (worst) to 100 (best)Vitamin D, n=11Placebo, n=11
Short Form 36 Survey39.1 (34.0 to 44.4)47.7 (42.5 to 52.9)

Adverse events

Collected over Adverse events were queried through specific and open ended questions at each study visit. All AEs after randomization were counted and reported.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vitamin D, n=11—0/11 (0%)1/11 (9.1%)
Placebo, n=11—0/11 (0%)0/11 (0%)
Most frequent other events
Most frequent other events
EventVitamin D, n=11Placebo, n=11
GIGastrointestinal disorders1/110/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Vitamin DPlaceboTotal
<=18 years000
Between 18 and 65 years6915
>=65 years527
Age, Continuous
Age, Continuous(years)Vitamin DPlaceboTotal
Mean63 ± 1253 ± 1158 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)Vitamin DPlaceboTotal
Female4610
Male7512
Region of Enrollment
Region of Enrollment(participants)Vitamin DPlaceboTotal
United States111122
08

Study locations

1 site
  • University of Wisconsin
    Madison, Wisconsin 53705, United States
09

References and documents

Publications

  • Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Engelke JA, Shafer MM. Vitamin D insufficiency: disease or no disease? J Bone Miner Res. 2008 Jul;23(7):1052-60. doi: 10.1359/jbmr.080230. PubMed 18302509 ↗
  • Hansen KE, Bartels CM, Gangnon RE, Jones AN, Gogineni J. An evaluation of high-dose vitamin D for rheumatoid arthritis. J Clin Rheumatol. 2014 Mar;20(2):112-4. doi: 10.1097/RHU.0000000000000072. No abstract available. PubMed 24561419 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00423358
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible party
Sponsor
First posted
Jan 18, 2007
Start date
Feb 2005
Primary completion
Aug 2008
Completion
Feb 2009
Results posted
Aug 24, 2015
Last update
Aug 24, 2015

Study contacts

Karen E Hansen, MD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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