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Annual intramuscular injection of a megadose of cholecalciferol for treatment of vitamin D deficiency: efficacy and safety data
Author(s) -
Diamond Terrence H,
Ho Kenneth W,
Rohl Peter G,
Meerkin Matthew
Publication year - 2005
Publication title -
medical journal of australia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 131
eISSN - 1326-5377
pISSN - 0025-729X
DOI - 10.5694/j.1326-5377.2005.tb06879.x
Subject(s) - cholecalciferol , vitamin d and neurology , parathyroid hormone , medicine , hypercalcaemia , intramuscular injection , vitamin d deficiency , secondary hyperparathyroidism , endocrinology , creatinine , hyperparathyroidism , vitamin , calcium
Aim: To evaluate the efficacy and safety of an annual intramuscular injection of cholecalciferol for vitamin D deficiency. Design: Prospective open‐label study. Participants: Five men and 45 women (mean age 66.3 years) with vitamin D deficiency who were given a single therapeutic intramuscular injection of 600 000 IU (15 mg) cholecalciferol (vitamin D 3 ). Outcome measures: Serum levels of calcium, creatinine, 25‐hydroxyvitamin D 3 (25OHD 3 ) and parathyroid hormone, as well as early morning 2‐hour urine calcium/creatinine excretion index. Specimens were collected at baseline and after 4 and 12 months of therapy. Data are reported as mean ± 1 SD. Results: Vitamin D deficiency was severe (< 12.5 nmol/L) in one participant, moderate (12.5–24 nmol/L) in 14, and mild (25–49 nmol/L) in 35. Twenty‐four participants (48%) had secondary hyperparathyroidism. Following intramuscular cholecalciferol injection, serum 25OHD 3 levels normalised in all participants and remained above 50 nmol/L throughout the study. Serum 25OHD 3 levels were significantly higher at 4 months (114 ± 35 nmol/L), and 12 months (73 ± 13 nmol/L) compared with baseline (32 ± 8 nmol/L) ( P < 0.001), increasing by an average of 128% over the 12 months. There was a corresponding decrease in serum parathyroid hormone levels at 4 months (6 ± 3 pmol/L) and at 12 months (5.2 ± 3 pmol/L), with a 30% decrease at 12 months from baseline (7.4 ± 4 pmol/L) ( P < 0.01). Primary hyperparathyroidism was unmasked in one participant at 4 months and mild hypercalcaemia (serum calcium, < 2.70 mmol/L) was noted in two participants (4%) at 12 months. Serum creatinine levels remained normal in all participants throughout the study, while increases in 2‐hour urine calcium/creatinine excretion index were seen in 10 participants (20%) at 12 months, three of whom had had elevated values at baseline. Conclusions: Once‐yearly intramuscular cholecalciferol injection (600 000 IU) is effective therapy for vitamin D deficiency. While this therapy appears to be safe, the potential for developing hypercalciuria needs to be examined in a large randomised controlled trial.