Efficacy and safety of high dose intramuscular or oral cholecalciferol in vitamin D deficient/insufficient elderly.

OBJECTIVES

To evaluate and compare the effects and safety of high dose intramuscular (IM) or oral cholecalciferol on 25-hydroxyvitamin D [25(OH)D] levels, muscle strength and physical performance in vitamin D deficient/insufficient elderly.

STUDY DESIGN

Randomized prospective study.

MAIN OUTCOME MEASURES

116 ambulatory individuals aged 65 years or older living in a nursing home were evaluated. Eligible patients with 25(OH)D levels <30 ng/ml (n=66) were randomized to IM or Oral groups according to the administration route of 600,000 IU cholecalciferol. Demographic and descriptive data were collected. Biochemical response was measured at baseline, 6th and 12th weeks. Muscle strength was measured from quadriceps by using a hand-held dynamometer and physical performance was evaluated by short physical performance battery (SPPB) at the beginning and 12th week.

RESULTS

Among the screened ambulatory elderly only 5.2% (n=6) had adequate vitamin D levels. 37.1% (n=43) were vitamin D deficient and 57.7% (n=67) were insufficient. After administration of one megadose of vitamin D, mean serum 25(OH)D levels increased significantly at 6th week (32.72±9.0 ng/ml) and at 12th week (52.34±14.2 ng/ml) compared with baseline (11.76±7.6 ng/ml) in IM group (p<0.0001). In Oral group levels were 47.57±12.7 ng/ml, 42.94±13.4 ng/ml and 14.87±6.9 ng/ml, respectively (p<0.0001). At 12th week the increase in IM group was significantly higher than Oral group (p=0.003). At the end of the study period, serum 25(OH)D levels were ≥30 ng/ml in all patients in IM group and in 83.3% of the patients in the Oral group. Quadriceps muscle strength and SPPB total score increased significantly in both groups and SPPB balance subscale score increased only in IM group. Six patients (9.6%) developed hypercalciuria, no significant adverse events were observed.

CONCLUSION

In vitamin D deficient/insufficient elderly, a single megadose of cholecalciferol increased vitamin D levels significantly and the majority of the patients reached optimal levels. Although both administration routes are effective and appear to be safe, IM application is more effective in increasing 25(OH)D levels and balance performance.