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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Gerencia de Atención Primaria, Albacete.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Gerencia de Atención Primaria, Albacete
ClinicalTrials.gov Identifier:
NCT01452243
First received: October 9, 2011
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Fall
Fractures
Drug: Vitamin D and calcium suplementation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)

Resource links provided by NLM:


Further study details as provided by Gerencia de Atención Primaria, Albacete:

Primary Outcome Measures:
  • Incidence of spontaneous falls. [ Time Frame: 24 months. ] [ Designated as safety issue: No ]
    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".


Secondary Outcome Measures:
  • Consequence of falls. [ Time Frame: 24 months. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Determined by dyanometry (with a mean of 3 attempts to obtain a muscle strength measurement).

  • Changes in musculoskeletal function. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 704
Study Start Date: November 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium and vitamin D
The pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452243

Locations
Spain
Research Unit. Primary Care Head Office of Albacete
Albacete, Spain, 02001
Sponsors and Collaborators
Gerencia de Atención Primaria, Albacete
Instituto de Salud Carlos III
Investigators
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerencia de Atención Primaria, Albacete
ClinicalTrials.gov Identifier: NCT01452243     History of Changes
Other Study ID Numbers: 2006001
Study First Received: October 9, 2011
Last Updated: October 11, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Gerencia de Atención Primaria, Albacete:
Vitamin D
Calcium
Elderly

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014