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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(12 )and folic acid on fracture incidence

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 B(12 )and folate status are associated with...

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Autores principales: van Wijngaarden, Janneke P, Dhonukshe-Rutten, Rosalie AM, van Schoor, Natasja M, van der Velde, Nathalie, Swart, Karin MA, Enneman, Anke W, van Dijk, Suzanne C, Brouwer-Brolsma, Elske M, Zillikens, M Carola, van Meurs, Joyce BJ, Brug, Johannes, Uitterlinden, André G, Lips, Paul, de Groot, Lisette CPGM
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3266639/
https://www.ncbi.nlm.nih.gov/pubmed/22136481
http://dx.doi.org/10.1186/1471-2318-11-80
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author van Wijngaarden, Janneke P
Dhonukshe-Rutten, Rosalie AM
van Schoor, Natasja M
van der Velde, Nathalie
Swart, Karin MA
Enneman, Anke W
van Dijk, Suzanne C
Brouwer-Brolsma, Elske M
Zillikens, M Carola
van Meurs, Joyce BJ
Brug, Johannes
Uitterlinden, André G
Lips, Paul
de Groot, Lisette CPGM
author_facet van Wijngaarden, Janneke P
Dhonukshe-Rutten, Rosalie AM
van Schoor, Natasja M
van der Velde, Nathalie
Swart, Karin MA
Enneman, Anke W
van Dijk, Suzanne C
Brouwer-Brolsma, Elske M
Zillikens, M Carola
van Meurs, Joyce BJ
Brug, Johannes
Uitterlinden, André G
Lips, Paul
de Groot, Lisette CPGM
author_sort van Wijngaarden, Janneke P
collection PubMed
description 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 B(12 )and folate status are associated with an increased fracture risk. As vitamin B(12 )and 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 μmol/L). One group receives daily a tablet with 500 μg vitamin B(12 )and 400 μg folic acid and the other group receives a placebo tablet. In both tablets 15 μg (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.e. bone mineral density and bone turnover markers, physical performance and physical activity including falls, nutritional intake and status, cognitive function, depression, genetics and quality of life. This large multi-center project is carried out by a consortium from the Erasmus MC (Rotterdam, the Netherlands), VUmc (Amsterdam, the Netherlands) and Wageningen University, (Wageningen, the Netherlands), the latter acting as coordinator. DISCUSSION: To our best knowledge, the B-PROOF study is the first intervention study in which the effect of vitamin B(12 )and folic acid supplementation on osteoporotic fractures is studied in a general elderly population. We expect the first longitudinal results of the B-PROOF intervention in the second semester of 2013. The results of this intervention will provide evidence on the efficacy of vitamin B(12 )and folate supplementation in the prevention of osteoporotic fractures. TRIAL REGISTRATION: The B-PROOF study is registered with the Netherlands Trial (NTR NTR1333) and with ClinicalTrials.gov (NCT00696514).
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spelling pubmed-32666392012-01-27 Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B(12 )and folic acid on fracture incidence van Wijngaarden, Janneke P Dhonukshe-Rutten, Rosalie AM van Schoor, Natasja M van der Velde, Nathalie Swart, Karin MA Enneman, Anke W van Dijk, Suzanne C Brouwer-Brolsma, Elske M Zillikens, M Carola van Meurs, Joyce BJ Brug, Johannes Uitterlinden, André G Lips, Paul de Groot, Lisette CPGM BMC Geriatr Study Protocol 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 B(12 )and folate status are associated with an increased fracture risk. As vitamin B(12 )and 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 μmol/L). One group receives daily a tablet with 500 μg vitamin B(12 )and 400 μg folic acid and the other group receives a placebo tablet. In both tablets 15 μg (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.e. bone mineral density and bone turnover markers, physical performance and physical activity including falls, nutritional intake and status, cognitive function, depression, genetics and quality of life. This large multi-center project is carried out by a consortium from the Erasmus MC (Rotterdam, the Netherlands), VUmc (Amsterdam, the Netherlands) and Wageningen University, (Wageningen, the Netherlands), the latter acting as coordinator. DISCUSSION: To our best knowledge, the B-PROOF study is the first intervention study in which the effect of vitamin B(12 )and folic acid supplementation on osteoporotic fractures is studied in a general elderly population. We expect the first longitudinal results of the B-PROOF intervention in the second semester of 2013. The results of this intervention will provide evidence on the efficacy of vitamin B(12 )and folate supplementation in the prevention of osteoporotic fractures. TRIAL REGISTRATION: The B-PROOF study is registered with the Netherlands Trial (NTR NTR1333) and with ClinicalTrials.gov (NCT00696514). BioMed Central 2011-12-02 /pmc/articles/PMC3266639/ /pubmed/22136481 http://dx.doi.org/10.1186/1471-2318-11-80 Text en Copyright ©2011 van Wijngaarden et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
van Wijngaarden, Janneke P
Dhonukshe-Rutten, Rosalie AM
van Schoor, Natasja M
van der Velde, Nathalie
Swart, Karin MA
Enneman, Anke W
van Dijk, Suzanne C
Brouwer-Brolsma, Elske M
Zillikens, M Carola
van Meurs, Joyce BJ
Brug, Johannes
Uitterlinden, André G
Lips, Paul
de Groot, Lisette CPGM
Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B(12 )and folic acid on fracture incidence
title Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B(12 )and folic acid on fracture incidence
title_full Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B(12 )and folic acid on fracture incidence
title_fullStr Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B(12 )and folic acid on fracture incidence
title_full_unstemmed Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B(12 )and folic acid on fracture incidence
title_short Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B(12 )and folic acid on fracture incidence
title_sort rationale and design of the b-proof study, a randomized controlled trial on the effect of supplemental intake of vitamin b(12 )and folic acid on fracture incidence
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3266639/
https://www.ncbi.nlm.nih.gov/pubmed/22136481
http://dx.doi.org/10.1186/1471-2318-11-80
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