Martin Soubrier1, Céline Lambert2, Bernard Combe3, Philippe Gaudin4, Thierry Thomas5, Jean Sibilia6, Maxime Dougados7, Jean-Jacques Dubost8. 1. Rheumatology Department, CHU Gabriel-Montpied, Clermont-Ferrand, France. msoubrier@chu-clermontferrand.fr. 2. Biostatistics Unit, CHU Gabriel-Montpied, Clermont-Ferrand, France. 3. Rheumatology Department, CHRU Montpellier, Montpellier University, France. 4. Rheumatology Department, CHU Grenoble, France. 5. Rheumatology Department, CHU Saint-Etienne, France. 6. Rheumatology Department, CHRU Strasbourg, France. 7. Rheumatology Department, Hopital Cochin, Paris, France. 8. Rheumatology Department, CHU Gabriel-Montpied, Clermont-Ferrand, France.
Abstract
OBJECTIVES: To evaluate the short-term efficacy of vitamin D (cholecalciferol) supplementation on functional disability in RA patients. METHODS: 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. RESULTS: 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). CONCLUSIONS: In this randomised, double-blind, placebo-controlled clinical trial in patients with RA and VitD deficiency, high doses ofcholecalciferol resulted in a statistically significant improvement in functional disability at month 6, which, however, was clinically not relevant.
RCT Entities:
OBJECTIVES: To evaluate the short-term efficacy of vitamin D (cholecalciferol) supplementation on functional disability in RApatients. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
Authors: Haneul Kim; Seungye Baek; Seung Min Hong; Jaeseon Lee; Seung Min Jung; Jennifer Lee; Mi La Cho; Seung Ki Kwok; Sung Hwan Park Journal: J Korean Med Sci Date: 2020-02-17 Impact factor: 2.153
Authors: Linda K Myers; Michael Winstead; John D Kee; Jeoungeun J Park; Sicheng Zhang; Wei Li; Ae-Kyung Yi; John M Stuart; Edward F Rosloniec; David D Brand; Robert C Tuckey; Andrzej T Slominski; Arnold E Postlethwaite; Andrew H Kang Journal: Int J Mol Sci Date: 2021-12-12 Impact factor: 5.923