NCT01452243|UnknownPhase 3
Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial
ANVITAD
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ANVITAD
Sponsor study identifier
interventional
704
1 country
1
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 9, 2011
Actual (reported)October 14, 2011
Actual (reported)November 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Consequence of falls.
24 months.
Change in calcidiol [25(OH)D3] plasma levels
18 months.
Change in bone mass (bone density or mineral content).
24 months.
Change in muscle strength in the dominant hand.
24 months
Changes in musculoskeletal function.
24 months
The pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Unit. Primary Care Head Office of Albacete
Albacete, Albacete, 02001, Spain
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.
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.
Jesús López-Torres, Hidalgo
Research Unit. Primary Care Head Office of Albacete
Ignacio Párraga Martínez, Dr.
Research Unit. Primary Care Head Office of Albacete
Beatriz Navarro Bravo, Dr.
Research Unit. Primary Care Head Office of Albacete
Fernando Andrés Pretel, Dr.
Research Unit. Primary Care Head Office of Albacete
First Submitted
October 9, 2011
First Posted
October 14, 2011
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2011
Ketamine Patient-Controlled Analgesia for Acute Pain
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pfeifer M, Begerow B, Minne HW. Vitamin D and muscle function. Osteoporos Int. 2002 Mar;13(3):187-94. doi: 10.1007/s001980200012.
Simon J, Leboff M, Wright J, Glowacki J. Fractures in the elderly and vitamin D. J Nutr Health Aging. 2002;6(6):406-12.
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.
van der Wielen RP, Lowik 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. doi: 10.1016/s0140-6736(95)91266-5.
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. doi: 10.1093/gerona/57.1.m7.
Zittermann A. Vitamin D in preventive medicine: are we ignoring the evidence? Br J Nutr. 2003 May;89(5):552-72. doi: 10.1079/BJN2003837.
Lopez-Torres Hidalgo J; ANVITAD Group. Prevention of falls and fractures in old people by administration of calcium and vitamin D, randomized clinical trial. BMC Public Health. 2011 Dec 9;11:910. doi: 10.1186/1471-2458-11-910.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 14, 2011
Record last verified: 2011-10
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