Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
研究概览
简要总结
Design paper:
Van Wijngaarden JP, Dhonukshe-Rutten RAM, van Schoor NM, van der Velde N, Swart KMA, Enneman AW, van Dijk SC, Brouwer-Brolsma EM, Zillikens MC, van Meurs JBJ, Brug J, Uitterlinden AG, Lips P, de Groot LCPGM. Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B12 and folic acid on fracture incidence. BMC Geriatr 2011;11:80 - Van Wijngaarden JP, Swart KMA, Enneman AW, Dhonukshe- Rutten, van Dijk SC, Brouwer-Brolsma EM, van der Zwaluw NL, Sohl E, van Meurs JBJ, Zillikens MC, van Schoor NM, van der Velde N, Brug J, Uitterlinden AG, Lips P, de Groot LCPGM. Effect of daily vitamin B12 and folic acid supplementation on fracture incidence in elderly with an elevated plasma homocysteine level: B-PROOF, a randomized controlled trial. Am J Clin Nutr 2014; 100(6):1578-1586.
- Paper with main outcomes:
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 65 years and older; based on entry date into study;
- •2. Fasting plasma Hcy level >= 12 µmol/L and < 50 µmol/L;
- •3. No current or recent (<4 months) use of supplements with very high doses of B-vitamins;
- •4. Competent to make own decisions;
- •5. Persons with skin cancer are allowed to participate;
- •6. Compliance to tablet intake > 85%;
- •7. Serum creatinine >150 µmol/L.
排除标准
- •1. Participation in other intervention trials;
- •2. Serious medical conditions, e.g. cancer diagnosis within the last 5 years or recent myocardial infarction;