Maturitas 72 (2012) 332–338 Contents lists available at SciVerse ScienceDirect Maturitas jo ur n al hom ep age : www.elsevier.com/locate/maturitas Efficacy and safety of high dose intramuscular or oral cholecalciferol in vitamin D deficient/insufficient elderly Ayse Tellioglu a , Sibel Basaran a,∗ , Rengin Guzel a , Gulsah Seydaoglu b a Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Cukurova University, Adana 01330, Turkey b Faculty of Medicine, Department of Biostatistics, Cukurova University, Adana 01330, Turkey a r t i c l e i n f o Article history: Received 1 December 2011 Received in revised form 19 April 2012 Accepted 24 April 2012 Keywords: Elderly Muscle strength Physical performance Vitamin D a b s t r a c t Objectives: To evaluate and compare the effects and safety of high dose intramuscular (IM) or oral cholecal- ciferol 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 mega- dose 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. © 2012 Elsevier Ireland Ltd. All rights reserved. 1. Introduction Vitamin D deficiency is now being recognized as one of the most common medical conditions in the world [1]. Vitamin D plays an important role in skeletal development, bone health maintenance and neuromuscular functioning. Since the signs and symptoms of vitamin D deficiency are insidious or nonspecific, it often goes unrecognized and untreated [2]. Frank vitamin D deficiency is defined as 25(OH)D below 10 ng per milliliter (ng/ml) and has long been recognized as a medical con- dition characterized by muscle weakness, bone pain, and fragility fractures. Vitamin D insufficiency is defined as 25(OH)D between 10 ∗ Corresponding author. Tel.: +90 322 3386429; fax: +90 322 3386429. E-mail address: sbasaran@cu.edu.tr (S. Basaran). and 30 ng/ml and levels equal or more than 30 ng/ml is considered as optimal [3]. The assessment of vitamin D deficiency/insufficiency preva- lence is being hampered by the different threshold levels used in different studies. Vitamin D deficiency is common among community-dwelling elderly in countries at higher latitudes and very common among institutionalized elderly, geriatric patients and patients with hip fractures [4]. Older people are especially at risk of developing vitamin D defi- ciency due to low exposure to sunshine, decreased capacity of the older skin to synthesize vitamin D, and low dietary vitamin D intake [5]. The prevalence of vitamin D deficiency among elderly people living in residential homes has been estimated to be at least 50% [6], and prevalence up to 75% has been reported [7]. Vitamin D deficiency has been shown to be associated with myopathy in subjects of various ages, with body sway in 0378-5122/$ – see front matter © 2012 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.maturitas.2012.04.011