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

NCT01452243 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 704

Last updated 2011-10-14

No results posted yet for this study

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.

Conditions

  • Fall
  • Fractures

Interventions

DRUG

Vitamin D and calcium suplementation

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.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Gerencia de Atención Primaria, Albacete

    lead OTHER

Principal Investigators

  • Jesús López-Torres, Hidalgo · Research Unit. Primary Care Head Office of Albacete

  • Ignacio Párraga Martínez, Dr. · Research Unit. Primary Care Head Office of Albacete

  • Beatriz Navarro Bravo, Dr. · Research Unit. Primary Care Head Office of Albacete

  • Fernando Andrés Pretel, Dr. · Research Unit. Primary Care Head Office of Albacete

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-11-30
Completion
2012-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452243 on ClinicalTrials.gov