Fall Clinical Trial
— ANVITADOfficial 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.
Status | Active, not recruiting |
Enrollment | 704 |
Est. completion date | April 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Research Unit. Primary Care Head Office of Albacete | Albacete |
Lead Sponsor | Collaborator |
---|---|
Gerencia de Atención Primaria, Albacete | Instituto de Salud Carlos III |
Spain,
Bischoff HA, Stähelin 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. — View Citation
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. Review. — View Citation
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. — View Citation
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 the elderly women. N Engl J Med. 1992 Dec 3;327(23):1637-42. — View Citation
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. — View Citation
del Campo MT, Aguado P, Martínez 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. Review. Spanish. — View Citation
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. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2005;(3):CD000227. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. Osteoporosis prevention, diagnosis, and therapy. JAMA. 2001 Feb 14;285(6):785-95. Review. — View Citation
Pfeifer M, Begerow B, Minne HW. Vitamin D and muscle function. Osteoporos Int. 2002 Mar;13(3):187-94. Review. — View Citation
Simon J, Leboff M, Wright J, Glowacki J. Fractures in the elderly and vitamin D. J Nutr Health Aging. 2002;6(6):406-12. Review. — View Citation
Vallecillo G, Díez A, Carbonell J, González Macías J. [Treatment of osteoporosis with calcium and vitamin D. Systematic review]. Med Clin (Barc). 2000 Jun 10;115(2):46-51. Review. Spanish. — View Citation
van der Wielen RP, Löwik MR, van den Berg H, de Groot LC, Haller J, Moreiras O, van Staveren WA. Serum vitamin D concentrations among elderly people in Europe. Lancet. 1995 Jul 22;346(8969):207-10. — View Citation
Zamboni M, Zoico E, Tosoni P, Zivelonghi A, Bortolani A, Maggi S, Di Francesco V, Bosello O. Relation between vitamin D, physical performance, and disability in elderly persons. J Gerontol A Biol Sci Med Sci. 2002 Jan;57(1):M7-11. — View Citation
Zittermann A. Vitamin D in preventive medicine: are we ignoring the evidence? Br J Nutr. 2003 May;89(5):552-72. Review. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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". | 24 months. | No |
Secondary | Consequence of falls. | Bone fractures at any location, need for healthcare, need for hospitalization, bed-ridden. | 24 months. | No |
Secondary | 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). | 18 months. | No |
Secondary | 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. | 24 months. | No |
Secondary | Change in muscle strength in the dominant hand. | Determined by dyanometry (with a mean of 3 attempts to obtain a muscle strength measurement). | 24 months | No |
Secondary | 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. | 24 months | No |
Secondary | 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. | 24 months. | Yes |
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