PMID- 30148432
STAT- Publisher
LR  - 20180827
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
DP  - 2018 Jul 18
TI  - A randomised, double-blind, placebo-controlled study assessing the efficacy of
      high doses of vitamin D on functional disability in patients with rheumatoid
AB  - 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 of
      cholecalciferol resulted in a statistically significant improvement in functional
      disability at month 6, which, however, was clinically not relevant.
FAU - Soubrier, Martin
AU  - Soubrier M
AD  - Rheumatology Department, CHU Gabriel-Montpied, Clermont-Ferrand, France.
FAU - Lambert, Celine
AU  - Lambert C
AD  - Biostatistics Unit, CHU Gabriel-Montpied, Clermont-Ferrand, France.
FAU - Combe, Bernard
AU  - Combe B
AD  - Rheumatology Department, CHRU Montpellier, Montpellier University, France.
FAU - Gaudin, Philippe
AU  - Gaudin P
AD  - Rheumatology Department, CHU Grenoble, France.
FAU - Thierry, Thomas
AU  - Thierry T
AD  - Rheumatology Department, CHU Saint-Etienne, France.
FAU - Sibilia, Jean
AU  - Sibilia J
AD  - Rheumatology Department, CHRU Strasbourg, France.
FAU - Dougados, Maxime
AU  - Dougados M
AD  - Rheumatology Department, Hopital Cochin, Paris, France.
FAU - Dubost, Jean-Jacques
AU  - Dubost JJ
AD  - Rheumatology Department, CHU Gabriel-Montpied, Clermont-Ferrand, France.
LA  - eng
PT  - Journal Article
DEP - 20180718
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
EDAT- 2018/08/28 06:00
MHDA- 2018/08/28 06:00
CRDT- 2018/08/28 06:00
PHST- 2017/11/23 00:00 [received]
PHST- 2018/03/19 00:00 [accepted]
PHST- 2018/08/28 06:00 [entrez]
PHST- 2018/08/28 06:00 [pubmed]
PHST- 2018/08/28 06:00 [medline]
AID - 12453 [pii]
PST - aheadofprint
SO  - Clin Exp Rheumatol. 2018 Jul 18. pii: 12453.