Overview

This trial is active, not recruiting.

Conditions fall, fractures
Treatment vitamin d and calcium suplementation
Phase phase 3
Sponsor Gerencia de Atención Primaria, Albacete
Collaborator Instituto de Salud Carlos III
Start date November 2008
End date November 2011
Trial size 704 participants
Trial identifier NCT01452243, 2006001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
The pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.
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.

Primary Outcomes

Measure
Incidence of spontaneous falls.
time frame: 24 months.

Secondary Outcomes

Measure
Consequence of falls.
time frame: 24 months.
Change in calcidiol [25(OH)D3] plasma levels
time frame: 18 months.
Change in bone mass (bone density or mineral content).
time frame: 24 months.
Change in muscle strength in the dominant hand.
time frame: 24 months
Changes in musculoskeletal function.
time frame: 24 months
Serious adverse events or any other adverse event.
time frame: 24 months.

Eligibility Criteria

Male or female participants at least 65 years old.

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).

Additional Information

Official title Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)
Principal investigator Jesús López-Torres, Hidalgo
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Gerencia de Atención Primaria, Albacete.