TY - JOUR
T1 - Annual intramuscular injection of a megadose of cholecalciferol for treatment of vitamin D deficiency
T2 - efficacy and safety data
AU - Diamond, Terrence H.
AU - Ho, Kenneth W.
AU - Rohl, Peter G.
AU - Meerkin, Matthew
PY - 2005/7/4
Y1 - 2005/7/4
N2 - 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 D3). Outcome measures: Serum levels of calcium, creatinine, 25-hydroxyvitamin D3 (25OHD3) 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 25OHD3 levels normalised in all participants and remained above 50 nmol/L throughout the study. Serum 25OHD3 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 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.
AB - 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 D3). Outcome measures: Serum levels of calcium, creatinine, 25-hydroxyvitamin D3 (25OHD3) 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 25OHD3 levels normalised in all participants and remained above 50 nmol/L throughout the study. Serum 25OHD3 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 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.
UR - http://www.scopus.com/inward/record.url?scp=21844460803&partnerID=8YFLogxK
M3 - Article
C2 - 15992330
AN - SCOPUS:21844460803
VL - 183
SP - 10
EP - 12
JO - Medical Journal of Australia
JF - Medical Journal of Australia
SN - 1326-5377
IS - 1
ER -