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Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B 12and folic acid on fracture incidence

Authors :
Wijngaarden, J.P. (Janneke) van
Dhonukshe-Rutten, R.A.M. (Rosalie)
Schoor, N.M. (Natasja) van
Velde, N. (Nathalie) van der
Swart, K.M.A. (Karin)
Enneman, A.W. (Anke)
Dijk, S.C. (Suzanne) van
Brouwer-Brolsma, E.M. (Elske)
Zillikens, M.C. (Carola)
Meurs, J.B.J. (Joyce) van
Brug, J. (Hans)
Uitterlinden, A.G. (André)
Lips, P. (Paul)
Groot, L.C.P.G.M. (Lisette) de
Wijngaarden, J.P. (Janneke) van
Dhonukshe-Rutten, R.A.M. (Rosalie)
Schoor, N.M. (Natasja) van
Velde, N. (Nathalie) van der
Swart, K.M.A. (Karin)
Enneman, A.W. (Anke)
Dijk, S.C. (Suzanne) van
Brouwer-Brolsma, E.M. (Elske)
Zillikens, M.C. (Carola)
Meurs, J.B.J. (Joyce) van
Brug, J. (Hans)
Uitterlinden, A.G. (André)
Lips, P. (Paul)
Groot, L.C.P.G.M. (Lisette) de
Publication Year :
2011

Abstract

Background: Osteoporosis is a major health problem, and the economic burden is expected to rise due to an increase in life expectancy throughout the world. Current observational evidence suggests that an elevated homocysteine concentration and poor vitamin B12and folate status are associated with an increased fracture risk. As vitamin B12and folate intake and status play a large role in homocysteine metabolism, it is hypothesized that supplementation with these B-vitamins will reduce fracture incidence in elderly people with an elevated homocysteine concentration. Methods/Design. The B-PROOF (B-Vitamins for the PRevention Of Osteoporotic Fractures) study is a randomized double-blind placebo-controlled trial. The intervention comprises a period of two years, and includes 2919 subjects, aged 65 years and older, independently living or institutionalized, with an elevated homocysteine concentration ( 12 mol/L). One group receives daily a tablet with 500 g vitamin B12and 400 g folic acid and the other group receives a placebo tablet. In both tablets 15 g (600 IU) vitamin D is included. The primary outcome of the study is osteoporotic fractures. Measurements are performed at baseline and after two years and cover bone health i

Details

Database :
OAIster
Notes :
application/pdf, BMC Geriatrics vol. 11, English
Publication Type :
Electronic Resource
Accession number :
edsoai.ocn929963164
Document Type :
Electronic Resource
Full Text :
https://doi.org/10.1186.1471-2318-11-80