Annual intramuscular injection of a megadose of cholecalciferol for treatment of vitamin D deficiency: efficacy and safety data.
OBJECTIVE
To evaluate the efficacy and safety of an annual intramuscular injection of cholecalciferol for vitamin D deficiency.


METHODS
Prospective open-label study.


METHODS
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)).


METHODS
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.
St George Hospital, University of New South Wales, Pritchard Wing Level 3, Gray Street, Kogarah, NSW 2217, Australia. terrydiamond@optushome.com.au
Terrence H
TH
Diamond
Kenneth W
KW
Ho
Peter G
PG
Rohl
Matthew
M
Meerkin
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002118:Calcium / Q000652:urine; D002762:Cholecalciferol / Q000008:administration & dosage*; D003404:Creatinine / Q000097:blood / Q000652:urine; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy / Q000209:etiology; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D011446:Prospective Studies; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014808:Vitamin D Deficiency / Q000145:classification / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism
D010281:Parathyroid Hormone; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D; D003404:Creatinine; D002118:Calcium