Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial

• Status: Unknown status
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gerencia de Atención Primaria, Albacete
• Collaborator: Instituto de Salud Carlos III
• Treatments: Calcium; Calcium, Dietary; Ergocalciferols; Vitamin D; Vitamins

Criteria

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).