Department of Human Nutrition, Wageningen University, P,O, Box 8129 6700 EV Wageningen, the Netherlands.
BMC Geriatr. 2011 Dec 2;11:80. doi: 10.1186/1471-2318-11-80.
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 B12 and folate status are associated with an increased fracture risk. As vitamin B12 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 B12 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.
To our best knowledge, the B-PROOF study is the first intervention study in which the effect of vitamin B12 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 B12 and folate supplementation in the prevention of osteoporotic fractures.
The B-PROOF study is registered with the Netherlands Trial (NTR NTR1333) and with ClinicalTrials.gov (NCT00696514).
骨质疏松症是一个主要的健康问题，由于全球预期寿命的延长，其经济负担预计将会增加。目前的观察性证据表明，高同型半胱氨酸浓度以及较差的维生素 B12 和叶酸状态与骨折风险增加有关。由于维生素 B12 和叶酸的摄入和状态在同型半胱氨酸代谢中起着重要作用，因此假设补充这些 B 族维生素将降低伴有高同型半胱氨酸浓度的老年人的骨折发生率。
方法/设计：B-PROOF（B 族维生素预防骨质疏松性骨折）研究是一项随机、双盲、安慰剂对照试验。该干预措施包括两年的时间，共纳入 2919 名年龄在 65 岁及以上、独立居住或居住在养老院、同型半胱氨酸浓度升高（≥12 μmol/L）的受试者。一组每天服用一片含有 500 μg 维生素 B12 和 400 μg 叶酸的片剂，另一组服用安慰剂片剂。两种片剂均含有 15 μg（600 IU）维生素 D。该研究的主要结局是骨质疏松性骨折。在基线和两年后进行测量，涵盖骨骼健康，即骨矿物质密度和骨转换标志物、身体机能和身体活动（包括跌倒）、营养摄入和状态、认知功能、抑郁、遗传学和生活质量。这个大型多中心项目由来自伊拉斯姆斯大学医学中心（荷兰鹿特丹）、VUmc（荷兰阿姆斯特丹）和瓦赫宁根大学（荷兰瓦赫宁根）的联盟开展，后者担任协调员。
据我们所知，B-PROOF 研究是第一项在普通老年人群中研究维生素 B12 和叶酸补充对骨质疏松性骨折影响的干预研究。我们预计 2013 年第二学期将首次公布 B-PROOF 干预的纵向结果。该干预研究的结果将提供关于维生素 B12 和叶酸补充预防骨质疏松性骨折疗效的证据。
B-PROOF 研究已在荷兰试验（NTR NTR1333）和临床试验（NCT00696514）中注册。
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