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Vitamins and Mineral for the Age of 50+: Vitamin D and Falls and Fractures

Friday, June 22, 2012 11:14

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Home of Kyle J. Norton for The Better of Living & Living Health Vitamin D, a group of fat-soluble secosteroids, is naturally present in very few foods, but can be synthesized in adequate amounts from sunlight.
There are associated of vitamin D serum levels in older persons with muscle strength, physical performance and risk of fractures and falls. In the Phase III, randomized, double blind, placebo-controlled trial to evaluate the efficacy of already marketed drugs in a new indication. It will be performed at Primary Care doctor visits at several Healthcare Centers in different Spanish Health Areas. A total of 704 non-institutionalized subjects aged 65 years or older will be studied (sample size calculated for a statistical power of 80%, alpha error 0.05, annual incidence of falls 30% and expected reduction of 30% to 20% and expected loss to follow up of 20%). The test drug containing 800 IU of vitamin D and 1000 mg of calcium will be administered daily. The control group will receive a placebo. The subjects will be followed up over two years. The primary variable will be the incidence of spontaneous falls. The secondary variables will include: consequences of the falls (fractures, need for hospitalization), change in calcidiol plasma levels and other analytical determinations (transaminases, PTH, calcium/phosphorous, albumin, creatinine, etc.), change in bone mass by densitometry, change in muscle strength in the dominant hand and change in musculoskeletal strength, risk factors for falls, treatment compliance, adverse effects and socio-demographic data(1).