Efficacy and safety of high dose intramuscular or oral cholecalciferol in vitamin D deficient/insufficient elderly
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 condition characterized by muscle weakness, bone pain, and fragility fractures. Vitamin D insufficiency is defined as 25(OH)D between 10 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 prevalence 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 deficiency 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 osteoporotic and fall-prone subjects and with falls in elderly, institutionalized subjects [8]. Studies investigating the effects of vitamin D supplementation and correlation between low 25(OH)D levels and physical performance have inconsistent results. Favorable effects of Vitamin D supplementation on muscle strength, physical performance and falls are shown in some studies [9], [10], whereas other studies have failed to show an increase in muscle strength [11], [12], [13].
Compliance to oral vitamin D replacement is usually low [14], [15], [16]. Only one in two postmenopousal women with osteoporosis who take calcium and/or vitamin D have good therapeutic adherence to this treatment [14]. Patients often find large tablets difficult to swallow and effervescent tablets combined with calcium may have gastrointestinal side effects [17]. Uncertain compliance to calcium and vitamin D replacement therapy gave rise to the idea of high-dose intermittent application of vitamin D. In Turkey, the general health insurance system pays for vitamin D in the form of oral drops or megadose ampoules or as effervescent tablets combined with calcium. Considering the suggested gastrointestinal and cardiovascular side effects of calcium [18], we are reluctant to prescribe combined effervescent preparations safely in the elderly. A daily requirement for vitamin D can also be replaced with oral vitamin D drops (Devit3® 50,000 IU/15 ml). In that case, the patients have to take approximately 8 drops per day, which they state to be unpractical and difficult to use. Therefore, it is needed to find a safe, practical and well-tolerated way of supplementation.
Several studies have investigated the pharmacokinetics, biochemical effects, efficacy and safety of a single high-dose cholecalciferol and revealed this application to be safe, well tolerated and effective [6], [11], [17], [19], [20].
The primary aim of this study is to evaluate and compare the effects and safety of high dose intramuscular (IM) or oral cholecalciferol on 25(OH)D levels in elderly patients with vitamin D deficiency or insufficiency. Besides, the clinical effects of this therapy are evaluated by muscle strength and physical performance measurements.
Section snippets
Methods
This study is conducted in Adana Nursing Home and Rehabilitation Center for the Elderly after obtaining permission from Republic of Turkey, Ministry of Family and Social Policy, Department of Elderly Care Services. Ethical approval was obtained from Cukurova University local ethics committee and all participants gave informed consent. The study was performed between November 2009 and March 2010.
Results
Ambulatory residents of the nursing home (56 women and 60 men) were evaluated for 25(OH)D levels. Only 5.2% (n = 6) of the patients had optimal levels of vitamin D. 37.1% of patients were vitamin D deficient (n = 43) and 57.7% (n = 67) were insufficient. The mean 25(OH)D level was 14.4 ± 8.5 ng/ml (4–46). The descriptive data of the study groups are given in Table 1. Baseline laboratory assessments, quadriceps muscle strength and SPPB scores are given in Table 2. No statistically significant differences
Discussion
Prevalence of vitamin D deficiency/insufficiency ranges between 7 and 80% depending on the defined cutpoint [24]. The prevalence of vitamin D deficiency among elderly people living in residential homes is higher than living in the community and has been estimated to be at least 50% [6], [25], [26].
Specific actions of vitamin D on target organs such as muscles or the nervous system influence balance and gait performance and therefore reduce falls. Some studies found a significant association
Contributors
Ayse Tellioglu participated with acquisition of data and drafting the article. Sibel Basaran participated with clinical leadership of the work including conception and design, collection of the data, data analysis and interpretation, and manuscript writing. Rengin Guzel participated with clinical leadership of the work including design, getting the permission for the study from the Department of Elderly Care Services, analysis of the results and preparation of the manuscript. Gulsah Seydaoglu
Competing interest
We do not have any conflicts of interests to declare.
Funding
The study was supported by the Research Fund of the Cukurova University. Project No. TF2009 LTP39.
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