A randomised, double-blind, placebo-controlled study assessing the efficacy of high doses of vitamin D on functional disability in patients with rheumatoid arthritis
M. Soubrier1, C. Lambert2, B. Combe3, P. Gaudin4, T. Thomas5, J. Sibilia6, M. Dougados7, J.-J. Dubost8
- Rheumatology Department, CHU Gabriel-Montpied, Clermont-Ferrand, France. email@example.com
- Biostatistics Unit, CHU Gabriel-Montpied, Clermont-Ferrand, France.
- Rheumatology Department, CHRU Montpellier, Montpellier University, France.
- Rheumatology Department, CHU Grenoble, France.
- Rheumatology Department, CHU Saint-Etienne, France.
- Rheumatology Department, CHRU Strasbourg, France.
- Rheumatology Department, Hopital Cochin, Paris, France.
- Rheumatology Department, CHU Gabriel-Montpied, Clermont-Ferrand, France.
2018 Vol.36, N°6
PI 1056, PF 1060
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PMID: 30148432 [PubMed]
Accepted : 19/03/2018
In Press: 18/07/2018
To evaluate the short-term efficacy of vitamin D (cholecalciferol) supplementation on functional disability in RA patients.
1) Patients: RA (ACR 1987 revised criteria) in non-remission (DAS28 >2.6) whose treatment was not expected to be changed over a 3-month period following inclusion and presenting with vitD deficits (serum 25OHD <30ng/mL). 2) Study design: prospective randomised placebo-controlled trial (NCT02243800). 3) Study arms: either vitD ampoules (cholecalciferol 100,000IU) or placebo. 4) Outcome measures: primary: improvement in patients’ functional disability using the Health Assessment questionnaire (HAQ); secondary: improvement in DAS28ESR, DAS28CRP, ESR, CRP, RAID score, fatigue (EVA and FACIT), and SF36.
Overall, 59 patients were included, 83.1% females, aged 59.8±10.9 years on average, with RA for 17.0±9.7 years. Thirty patients received placebo and 29 vitD. At 6 months, HAQ scores tended to be increased in the placebo group (+0.08±0.25), while slightly numerically decreased in the vitD group (-0.03±0.23) (p=0.11). After adjusting for age, gender, season, and initial vitD status, the between-group difference achieved statistically significance (p=0.046). After adjusting for age, gender, season, and initial vitD status, there was no significant difference in the secondary criteria between the 2 groups except for ESR and CRP (p=0.002 and 0.04, respectively).
In this randomised, double-blind, placebo-controlled clinical trial in patients with RA and VitD deficiency, high doses of cholecalciferol resulted in a statistically significant improvement in functional disability at month 6, which, however, was clinically not relevant.