Objectives To assess the efficacy and safety of ergocalciferol in combination with standard care in patients with systemic lupus erythematosus (SLE)
Methods A randomized, double-blinded, placebo-comparative study was conducted in SLE with mild-moderate disease activity. The patients were randomized to receive either high doses of vitamin D (100,000 IU of ergocalciferol weekly for 4 weeks followed by 40,000 IU of ergocalciferol weekly for 20 weeks) or placebo. All patients received 800 unit of cholecalciferol daily for 24 weeks. Concurrent medications could be adjusted as clinically required. Efficacy measures were SLE disease activity index (SLEDAI) score, SLE Flare Index (SFI), inflammatory markers, and dosage of immunosuppressive drugs. The study was approved by the ethic committee and institutional review board
Results Of the 104 patients enrolled, 88 patients completed the study. Baseline characteristics were similar. At 24 weeks, the mean ± standard difference (SD) of serum 25(OH)D in patients who received high doses of vitamin D was significantly higher than placebo group (41.2 ± 14.4 vs. 27.2 ± 10.1, p<0.001). There was no difference between patients who received high doses of vitamin D and placebo in respect of SLEDAI, SFI, inflammatory markers, and dosage of immunosuppressive drugs. However, at 12 and 24 weeks, the number of patient who can reduce prednisolone dosages in patients who received high doses of vitamin D were significantly greater than that of the placebo (39.6% vs.17.6%, p=0.008) and (43.4% vs. 23.5%, p=0.013). Adverse reactions in both groups were similar. Serum calcium levels did not change within and between groups of treatment.
Conclusions This study could not demonstrate the efficacy of high dose ergocalciferol in controlling SLE disease activity. However, high dose ergocalciferol could be an adjunctive therapy that safe and has a corticosteroid-sparing effect on patients with SLE
Disclosure of Interest None declared