Prevention of falls and fractures in old people by administration of calcium and vitamin D, randomized clinical trial.
Background: There are many studies that associate vitamin D serum levels in older persons with muscle strength, physical performance and risk of fractures and falls. However, current evidence is insufficient to make a general recommendation for administrating calcium and vitamin D to older persons....
| Publicado en: | BMC Public Health Vol. 11; no. 1; pp. 910 - 911 |
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| Autor principal: | |
| Formato: | research randomized controlled trial Journal Article |
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BioMed Central
2011
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104497881&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104497881 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 14712458 1CIK jtl: BMC Public Health issn: 14712458 maglogo: N pubinfo: dt: 2011 vid: 11 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 104497881 104497881 NLM22151975 2011655141 10.1186/1471-2458-11-910 NLM22151975 PMC3267804 104497881 ppf: 910 ppct: 1 formats: tig: atl: Prevention of falls and fractures in old people by administration of calcium and vitamin D, randomized clinical trial. aug: au: López-Torres Hidalgo, Jesús sug: subj: Accidental Falls Prevention and Control Calcium Administration and Dosage Dietary Supplements Fractures Prevention and Control Primary Health Care Methods Vitamin D Administration and Dosage Aged Calcium Adverse Effects Calcium Blood Diphosphonates Administration and Dosage Diphosphonates Adverse Effects Diphosphonates Blood Double-Blind Studies Drug Administration Schedule Female Human Male Muscle Strength Physiology Office Visits Statistics and Numerical Data Patient Compliance Prospective Studies Quality of Life Randomized Controlled Trials Recovery Relative Risk Spain Survival Analysis Treatment Outcomes Vitamin D Deficiency Prevention and Control Vitamin D Adverse Effects Vitamin D Blood Aged: 65+ years Female Male ab: Background: There are many studies that associate vitamin D serum levels in older persons with muscle strength, physical performance and risk of fractures and falls. However, current evidence is insufficient to make a general recommendation for administrating calcium and vitamin D to older persons. The objective of this study is to determine the effectiveness of calcium and vitamin D supplementation in improving musculoskeletal function and decreasing the number of falls in person aged over 65 years.Methods/design: 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.Discussion: The following principles have been considered in the development of this Project: the product data are sufficient to ensure that the risks assumed by the study participants are acceptable, the study objectives will probably provide further knowledge on the problem studied and the available information justifies the performance of the study and its possible risk for the participants.If calcium and vitamin D supplementation is effective in the prevention of falls and fractures in the elderly population, a recommendation may be issued with the aim of preventing some of the consequences of falls that affect quality of life and the ensuing personal, health and social costs.Trial Registration: ClinicalTrials.gov: NCT01452243 pubtype: Academic Journal doctype: research randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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