NCT01452243

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
704

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 14, 2011

Status Verified

October 1, 2011

Enrollment Period

3 years

First QC Date

October 9, 2011

Last Update Submit

October 11, 2011

Conditions

FallFractures

Keywords

Vitamin DCalciumElderly

Outcome Measures

Primary Outcomes (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".

    24 months.

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Calcium and vitamin D

EXPERIMENTAL

The pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.

Drug: Vitamin D and calcium suplementation

Interventions

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.

Calcium and vitamin D

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit. Primary Care Head Office of Albacete

Albacete, Albacete, 02001, Spain

Location

Related Publications (19)

  • 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.

    PMID: 12568412BACKGROUND

  • 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.

    PMID: 15886381BACKGROUND

  • 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.

    PMID: 9366737BACKGROUND

  • 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.

    PMID: 1331788BACKGROUND

  • 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.

    PMID: 11991447BACKGROUND

  • 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.

    PMID: 16373031BACKGROUND

  • 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.

    PMID: 12009020BACKGROUND

  • 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.

    PMID: 11279685BACKGROUND

  • 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.

    PMID: 11916748BACKGROUND

  • 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.

    PMID: 12919233BACKGROUND

  • 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.

    PMID: 8554248BACKGROUND

  • 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.

    PMID: 11176917BACKGROUND

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

    PMID: 11991436BACKGROUND

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

    PMID: 12459891BACKGROUND

  • 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.

    PMID: 10934692BACKGROUND

  • 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.

    PMID: 7616799BACKGROUND

  • 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.

    PMID: 11773206BACKGROUND

  • 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.

    PMID: 12720576BACKGROUND

  • 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.

    PMID: 22151975DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jesús López-Torres, Hidalgo

    Research Unit. Primary Care Head Office of Albacete

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2011

First Posted

October 14, 2011

Study Start

November 1, 2008

Primary Completion

November 1, 2011

Study Completion

April 1, 2012

Last Updated

October 14, 2011

Record last verified: 2011-10

Locations

ES(1)