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

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ClinicalTrials.gov Identifier: NCT01452243
Recruitment Status : Unknown
Verified October 2011 by Gerencia de Atención Primaria, Albacete.
Recruitment status was:  Active, not recruiting
First Posted : October 14, 2011
Last Update Posted : October 14, 2011
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Gerencia de Atención Primaria, Albacete

Tracking Information
First Submitted Date  ICMJE October 9, 2011
First Posted Date  ICMJE October 14, 2011
Last Update Posted Date October 14, 2011
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
Incidence of spontaneous falls. [ Time Frame: 24 months. ]
The primary variable will be the incidence of spontaneous falls according to the FICSIT (Frailty and Injury: Cooperative Study of Intervention Techniques) definition: "Unintentionally coming to rest on the ground, floor, or other lower level. Coming to rest against furniture or a wall was not counted as a fall".
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
  • Consequence of falls. [ Time Frame: 24 months. ]
    Bone fractures at any location, need for healthcare, need for hospitalization, bed-ridden.
  • Change in calcidiol [25(OH)D3] plasma levels [ Time Frame: 18 months. ]
    Determined by RIA (Vitamin D deficiency is defined as a calcidiol plasma level lower than 10ng/ml).
  • Change in bone mass (bone density or mineral content). [ Time Frame: 24 months. ]
    By densitometry (risk of fracture). Osteoporosis will be diagnosed based on a densitometry T-score of less than 2.5 in the vertebral column, according to WHO criteria.
  • Change in muscle strength in the dominant hand. [ Time Frame: 24 months ]
    Determined by dyanometry (with a mean of 3 attempts to obtain a muscle strength measurement).
  • Changes in musculoskeletal function. [ Time Frame: 24 months ]
    By the timed up and go test (the elderly person gets up from a chair with arms, walks three meters, turns round, walks back and sits down again). Taking more than 20 seconds indicates a high risk for falls.
  • Serious adverse events or any other adverse event. [ Time Frame: 24 months. ]
    An adverse event is considered as any untoward medical occurrence in any patient included in the study which does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial
Official Title  ICMJE Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)
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-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.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Fall
  • Fractures
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Calcium and vitamin D
The pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.
Intervention: Drug: Vitamin D and calcium suplementation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 11, 2011)
704
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2012
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01452243
Other Study ID Numbers  ICMJE 2006001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerencia de Atención Primaria, Albacete
Study Sponsor  ICMJE Gerencia de Atención Primaria, Albacete
Collaborators  ICMJE Instituto de Salud Carlos III
Investigators  ICMJE
Principal Investigator: Jesús López-Torres, Hidalgo Research Unit. Primary Care Head Office of Albacete
Study Chair: Ignacio Párraga Martínez, Dr. Research Unit. Primary Care Head Office of Albacete
Study Chair: Beatriz Navarro Bravo, Dr. Research Unit. Primary Care Head Office of Albacete
Study Chair: Fernando Andrés Pretel, Dr. Research Unit. Primary Care Head Office of Albacete
PRS Account Gerencia de Atención Primaria, Albacete
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP