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eISSN: 1643-3750

Efficacy and Safety of 22-Oxa-Calcitriol in Patients with Rheumatoid Arthritis: A Phase II Trial

Chaohong Li, Songlou Yin, Hanqiu Yin, Lina Cao, Ting Zhang, Yong Wang

(Department of Rheumatology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland))

Med Sci Monit 2018; 24:9127-9135

DOI: 10.12659/MSM.911628

Published: 2018-12-16


BACKGROUND: Calcitriol (1 alpha, 25-dihydroxy vitamin D3) is a good vitamin D supplement but can cause hypercalcemia. Whereas, 22-oxa-1 alpha, 25-dihydroxy vitamin D3 (22-oxa-calcitriol) has less hypercalcemic activity than calcitriol and is reported to be effective for cell-proliferative diseases. The objective of the study was to compare renal function and blood tests of arthritis patients receiving calcitriol supplements with those receiving 22-oxa-calcitriol supplements.
MATERIAL AND METHODS: A total of 369 patients with clinically confirmed rheumatoid arthritis were included in this phase II trial. Patients received lactose powder (the placebo group, n=123), 50 000 IU/week of 22-oxa-calcitriol (the treatment group, n=123), or 50 000 IU/week of calcitriol (the control group, n=123) for 6 weeks. At the time of enrollment and after 6 weeks of supplementation, renal function tests, blood tests, and secondary outcome measures were evaluated. One-way ANOVA and the chi-squared test for independence were performed for continuous data and constant data at a 95% of confidence level.
RESULTS: Both 22-oxa-calcitriol and calcitriol successfully decreased swollen joints in patients with rheumatoid arthritis, and both improved Health Assessment Questionnaire Disease Activity Index scores and serum vitamin D levels. The intensity of improvement of serum vitamin D levels in both groups was the same (P<0.0001, q=0.24); however, calcitriol caused hypercalcemia (P<0.0001, q=12.59).
CONCLUSIONS: This study found that 22-oxa-calcitriol was a good option for vitamin D supplementation in rheumatoid arthritis patients.

Keywords: Blood Sedimentation, Calcitriol, Felty syndrome, Hypercalcemia, Vascular Stiffness, Vitamin D Deficiency



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