Title
Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial
Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)
Phase
Phase 3Lead Sponsor
Gerencia de Atención Primaria, AlbaceteStudy Type
InterventionalStatus
Unknown statusIntervention/Treatment
vitamin d3 calcium ...Study Participants
704The first objective is to determine the efficacy of calcium and vitamin D supplementation at doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in non-institutionalized elderly people.
The second objective is to measure and compare treatment groups (calcium and vitamin D vs placebo) as regards muscle strength and musculoskeletal function, bone mineral density, calcidiol level and treatment safety.
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.
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.
The pharmacological intervention will be the daily administration of chewable tablets containing 800 IU of vitamin D and 1200 mg of calcium. They will be administered over 2 years during the months of November to April in order to avoid the influence of sunlight.
The pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.
Inclusion Criteria: Aged over 65 years with normal renal function Normal transaminase levels Normal calcium blood levels Not homebound (not immobilized) nor in socio-healthcare institutions. Exclusion Criteria: Need for medical treatment with calcium or vitamin D Hypersensitivity to or contraindication for calcium or vitamin D Medical treatment that includes calcium or vitamin D Physical disability that impedes their collaboration Taking thiazide diuretics Oral anticoagulants Hormone replacement therapy Digitalis drugs Anticonvulsants or barbiturates Having any of the following diseases: Lithiasis Renal impairment (serum creatinine >1.4 mg/dl) Hypo or hyperthyroidism Paget's disease Chronic liver disease Tumors Sarcoidosis Impaired intestinal absorption or chronic alcoholism (>40 g/day).
