Treatment of hypovitaminosis D with pharmacologic doses of cholecalciferol, oral vs intramuscular; an open labeled RCT

Abstract

Objective: Vitamin D deficiency is a worldwide health problem. Usual supplements are inadequate for prevention of hypovitaminosis D, and much higher doses are needed for its treatment. This study was designed to compare the efficacy and practicality of high-dose intramuscular and oral cholecalciferol in treatment of hypovitaminosis D and to evaluate durability of the effect of each remedy.

Design: Ninety-two patients with hypovitaminosis D [serum 25(OH) D level < 75 nmol/l] were enrolled in a randomised clinical trial. Participants were randomly assigned to receive 300 000 IU cholecalciferol, either intramuscularly as a single injection or orally in six divided doses during 3 months period. Serum 25(OH) D level was measured at baseline and at 3 and 6 months.

Results: Both treatment regimens significantly increased the serum 25(OH)D level. Delta change in serum 25(OH) D level from baseline (presented as mean ± SEM) at month 3 was significantly higher in oral than injection group (90 ± 11·2 and 58·8 ± 8·9 nmol/l, respectively, P = 0·03); but was similar at 6th month intervention (52·1 ± 7·6 and 62·2 ± 6·7 nmol/l, respectively, P = 0·32). There was a marginally significant trend in favour of oral group in the proportion of cases attained vitamin D adequacy at 6th month (P = 0·06); but still 15% of all patients remained at < 50 nmol/l.

Conclusion: Both regimens were considerably effective, safe and practical in treating hypovitaminosis D. Although we revealed superiority of oral route, at least at early short time, the way of treatment may depend on the patient's choice, compliance and availability of various forms of the drug in any regions.