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FallPhase 3ANVITADNCT01452243

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

A Phase 3 study testing Vitamin D and calcium suplementation in people with Fall and Fractures, run by Gerencia de Atención Primaria, Albacete at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Fall, Fractures
What is being tested?
Vitamin D and calcium suplementation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
704 participants
Where
1 siteSpain
Study dates
Nov 2008to Apr 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Aged over 65 years with normal renal function
  • Normal transaminase levels
  • Normal calcium blood levels
  • Not homebound (not immobilized) nor in socio-healthcare institutions.

Who cannot join

  • 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
Show all 18Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Research Unit. Primary Care Head Office of Albacete

    Albacete, Albacete, 02001

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
Fall, Fractures
Being tested
Vitamin D and calcium suplementation
Keywords
Vitamin D, Calcium, Elderly
Medical subject headings
Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D and calcium suplementationDrug

    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 groups in NCT01452243
Study groupRoleWhat they receive
Calcium and vitamin DExperimentalThe pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.
Receives: Drug: Vitamin D and calcium suplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of spontaneous falls.

    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".

    Measured: 24 months.

Secondary outcomes (6)

  1. Consequence of falls.

    Bone fractures at any location, need for healthcare, need for hospitalization, bed-ridden.

    Measured: 24 months.

  2. Change in calcidiol [25(OH)D3] plasma levels

    Determined by RIA (Vitamin D deficiency is defined as a calcidiol plasma level lower than 10ng/ml).

    Measured: 18 months.

  3. Change in bone mass (bone density or mineral content).

    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.

    Measured: 24 months.

  4. Change in muscle strength in the dominant hand.

    Determined by dyanometry (with a mean of 3 attempts to obtain a muscle strength measurement).

    Measured: 24 months

  5. Changes in musculoskeletal function.

    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.

    Measured: 24 months

  6. Serious adverse events or any other adverse event.

    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.

    Measured: 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2011 (estimated)
  2. Study startNov 2008
  3. Primary completionNov 2011 (estimated)
  4. Study completionApr 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
704 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01452243
Sponsor's protocol ID
2006001
Acronym
ANVITAD
Status last verified
Oct 2011
First submitted
9 Oct 2011
Last updated
14 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • Bischoff HA, Stahelin HB, Dick W, Akos R, Knecht M, Salis C, Nebiker M, Theiler R, Pfeifer M, Begerow B, Lew RA, Conzelmann M. Effects of vitamin D and calcium supplementation on falls: a randomized controlled trial. J Bone Miner Res. 2003 Feb;18(2):343-51. doi: 10.1359/jbmr.2003.18.2.343.

    PubMed 12568412

  • Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA. 2005 May 11;293(18):2257-64. doi: 10.1001/jama.293.18.2257.

    PubMed 15886381

  • Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9. doi: 10.1136/bmj.315.7115.1065.

    PubMed 9366737

  • Chapuy MC, Arlot ME, Duboeuf F, Brun J, Crouzet B, Arnaud S, Delmas PD, Meunier PJ. Vitamin D3 and calcium to prevent hip fractures in elderly women. N Engl J Med. 1992 Dec 3;327(23):1637-42. doi: 10.1056/NEJM199212033272305.

    PubMed 1331788

  • Chapuy MC, Pamphile R, Paris E, Kempf C, Schlichting M, Arnaud S, Garnero P, Meunier PJ. Combined calcium and vitamin D3 supplementation in elderly women: confirmation of reversal of secondary hyperparathyroidism and hip fracture risk: the Decalyos II study. Osteoporos Int. 2002 Mar;13(3):257-64. doi: 10.1007/s001980200023.

    PubMed 11991447

  • del Campo MT, Aguado P, Martinez ME. [Vitamin D and bone health: is there a need to review supplementation in osteoporosis risk population?]. Med Clin (Barc). 2005 Dec 3;125(20):788-93. doi: 10.1016/s0025-7753(05)72191-6. Spanish.

    PubMed 16373031

  • Dhesi JK, Bearne LM, Moniz C, Hurley MV, Jackson SH, Swift CG, Allain TJ. Neuromuscular and psychomotor function in elderly subjects who fall and the relationship with vitamin D status. J Bone Miner Res. 2002 May;17(5):891-7. doi: 10.1359/jbmr.2002.17.5.891.

    PubMed 12009020

  • Gillespie WJ, Avenell A, Henry DA, O'Connell DL, Robertson J. Vitamin D and vitamin D analogues for preventing fractures associated with involutional and post-menopausal osteoporosis. Cochrane Database Syst Rev. 2001;(1):CD000227. doi: 10.1002/14651858.CD000227.

    PubMed 11279685

  • Janssen HC, Samson MM, Verhaar HJ. Vitamin D deficiency, muscle function, and falls in elderly people. Am J Clin Nutr. 2002 Apr;75(4):611-5. doi: 10.1093/ajcn/75.4.611.

    PubMed 11916748

  • Latham NK, Anderson CS, Reid IR. Effects of vitamin D supplementation on strength, physical performance, and falls in older persons: a systematic review. J Am Geriatr Soc. 2003 Sep;51(9):1219-26. doi: 10.1046/j.1532-5415.2003.51405.x.

    PubMed 12919233

  • Lips P, Graafmans WC, Ooms ME, Bezemer PD, Bouter LM. Vitamin D supplementation and fracture incidence in elderly persons. A randomized, placebo-controlled clinical trial. Ann Intern Med. 1996 Feb 15;124(4):400-6. doi: 10.7326/0003-4819-124-4-199602150-00003.

    PubMed 8554248

  • NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. Osteoporosis prevention, diagnosis, and therapy. JAMA. 2001 Feb 14;285(6):785-95. doi: 10.1001/jama.285.6.785.

    PubMed 11176917

  • Pfeifer M, Begerow B, Minne HW. Vitamin D and muscle function. Osteoporos Int. 2002 Mar;13(3):187-94. doi: 10.1007/s001980200012.

    PubMed 11991436

  • Simon J, Leboff M, Wright J, Glowacki J. Fractures in the elderly and vitamin D. J Nutr Health Aging. 2002;6(6):406-12.

    PubMed 12459891

  • Vallecillo G, Diez A, Carbonell J, Gonzalez Macias J. [Treatment of osteoporosis with calcium and vitamin D. Systematic review]. Med Clin (Barc). 2000 Jun 10;115(2):46-51. doi: 10.1016/s0025-7753(00)71461-8. Spanish.

    PubMed 10934692

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin D and calcium suplementation in people with Fall and Fractures, run by Gerencia de Atención Primaria, Albacete at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of spontaneous falls. (time frame: 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01452243, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2011.

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