Status:
UNKNOWN
Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial
Lead Sponsor:
Gerencia de Atención Primaria, Albacete
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Fall
Fractures
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief 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-institutio...
Detailed Description
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 insu...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
704 Patients enrolled
Trial Details
Trial ID
NCT01452243
Start Date
November 1 2008
End Date
April 1 2012
Last Update
October 14 2011
Active Locations (1)
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1
Research Unit. Primary Care Head Office of Albacete
Albacete, Albacete, Spain, 02001