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Effect of Combination Folic Acid, Vitamin B6 , and Vitamin B12 Supplementation on Fracture Risk in Women: A Randomized, Controlled Trial.
J Bone Miner Res 2017; 32(12):2331-2338JB

Abstract

Epidemiologic studies have demonstrated an association of elevated plasma homocysteine levels with greater bone resorption and fracture risk. Vitamins B12 , B6 , and folic acid are cofactors in homocysteine metabolism, and supplementation with B vitamins is effective in lowering homocysteine levels in humans. However, randomized trials of supplemental B vitamins for reduction of fracture risk have been limited. Therefore, we performed an ancillary study to the Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS), a large randomized trial of women with preexisting cardiovascular disease or three or more coronary risk factors, to test whether a daily B vitamin intervention including folic acid (2.5 mg/day), vitamin B6 (50 mg/day), and vitamin B12 (1 mg/day) reduces nonspine fracture risk over 7.3 years of treatment and follow-up. Among 4810 women, we confirmed 349 nonspine fracture cases by centralized review of medical records. In a substudy of 300 women (150 in treatment group and 150 controls) with paired plasma samples at randomization and follow-up (7.3 years later), we measured two bone turnover markers, including C-terminal cross-linking telopeptide of type I collagen (CTX) and intact type I procollagen N-propeptide (P1NP). In Cox proportional hazards models based on intention-to-treat, we found no significant effects of B vitamin supplementation on nonspine fracture risk (relative hazard = 1.08; 95% confidence interval, 0.88 to 1.34). In a nested case-cohort analysis, there were no significant effects of B vitamins on fracture risk among women with elevated plasma homocysteine levels, or low levels of vitamins B12 or B6 , or folate at baseline. Furthermore, treatment with B vitamins had no effect on change in markers of bone turnover. We found no evidence that daily supplementation with B vitamins reduces fracture risk or rates of bone metabolism in middle-aged and older women at high risk of cardiovascular disease. © 2017 American Society for Bone and Mineral Research.

Authors+Show Affiliations

Research Institute, California Pacific Medical Center, San Francisco, CA, USA. Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.Research Institute, California Pacific Medical Center, San Francisco, CA, USA.Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.Vitamin Metabolism Laboratory, Jean Mayer United States Department of Agriculture (USDA) Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA. Institute of Biochemistry, Food and Nutrition Science, The Robert H. Smith Faculty of Agriculture Food and Environment, The Hebrew University of Jerusalem, Jerusalem, Israel.Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.Department of Family Medicine & Public Health, University of California, San Diego, San Diego, CA, USA. Department of Internal Medicine, University of California, San Diego, San Diego, CA, USA.Research Institute, California Pacific Medical Center, San Francisco, CA, USA.Research Institute, California Pacific Medical Center, San Francisco, CA, USA. Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29244251

Citation

Stone, Katie L., et al. "Effect of Combination Folic Acid, Vitamin B6 , and Vitamin B12 Supplementation On Fracture Risk in Women: a Randomized, Controlled Trial." Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, vol. 32, no. 12, 2017, pp. 2331-2338.
Stone KL, Lui LY, Christen WG, et al. Effect of Combination Folic Acid, Vitamin B6 , and Vitamin B12 Supplementation on Fracture Risk in Women: A Randomized, Controlled Trial. J Bone Miner Res. 2017;32(12):2331-2338.
Stone, K. L., Lui, L. Y., Christen, W. G., Troen, A. M., Bauer, D. C., Kado, D., ... Manson, J. E. (2017). Effect of Combination Folic Acid, Vitamin B6 , and Vitamin B12 Supplementation on Fracture Risk in Women: A Randomized, Controlled Trial. Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, 32(12), pp. 2331-2338. doi:10.1002/jbmr.3229.
Stone KL, et al. Effect of Combination Folic Acid, Vitamin B6 , and Vitamin B12 Supplementation On Fracture Risk in Women: a Randomized, Controlled Trial. J Bone Miner Res. 2017;32(12):2331-2338. PubMed PMID: 29244251.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Combination Folic Acid, Vitamin B6 , and Vitamin B12 Supplementation on Fracture Risk in Women: A Randomized, Controlled Trial. AU - Stone,Katie L, AU - Lui,Li-Yung, AU - Christen,William G, AU - Troen,Aron M, AU - Bauer,Douglas C, AU - Kado,Deborah, AU - Schambach,Christopher, AU - Cummings,Steven R, AU - Manson,JoAnn E, PY - 2017/03/20/received PY - 2017/07/25/revised PY - 2017/07/27/accepted PY - 2017/12/16/entrez PY - 2017/12/16/pubmed PY - 2018/7/24/medline KW - B VITAMINS KW - BIOCHEMICAL MARKERS OF BONE TURNOVER KW - FRACTURE PREVENTION KW - NUTRITION KW - OSTEOPOROSIS KW - THERAPEUTICS SP - 2331 EP - 2338 JF - Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research JO - J. Bone Miner. Res. VL - 32 IS - 12 N2 - Epidemiologic studies have demonstrated an association of elevated plasma homocysteine levels with greater bone resorption and fracture risk. Vitamins B12 , B6 , and folic acid are cofactors in homocysteine metabolism, and supplementation with B vitamins is effective in lowering homocysteine levels in humans. However, randomized trials of supplemental B vitamins for reduction of fracture risk have been limited. Therefore, we performed an ancillary study to the Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS), a large randomized trial of women with preexisting cardiovascular disease or three or more coronary risk factors, to test whether a daily B vitamin intervention including folic acid (2.5 mg/day), vitamin B6 (50 mg/day), and vitamin B12 (1 mg/day) reduces nonspine fracture risk over 7.3 years of treatment and follow-up. Among 4810 women, we confirmed 349 nonspine fracture cases by centralized review of medical records. In a substudy of 300 women (150 in treatment group and 150 controls) with paired plasma samples at randomization and follow-up (7.3 years later), we measured two bone turnover markers, including C-terminal cross-linking telopeptide of type I collagen (CTX) and intact type I procollagen N-propeptide (P1NP). In Cox proportional hazards models based on intention-to-treat, we found no significant effects of B vitamin supplementation on nonspine fracture risk (relative hazard = 1.08; 95% confidence interval, 0.88 to 1.34). In a nested case-cohort analysis, there were no significant effects of B vitamins on fracture risk among women with elevated plasma homocysteine levels, or low levels of vitamins B12 or B6 , or folate at baseline. Furthermore, treatment with B vitamins had no effect on change in markers of bone turnover. We found no evidence that daily supplementation with B vitamins reduces fracture risk or rates of bone metabolism in middle-aged and older women at high risk of cardiovascular disease. © 2017 American Society for Bone and Mineral Research. SN - 1523-4681 UR - https://www.unboundmedicine.com/medline/citation/29244251/Effect_of_Combination_Folic_Acid_Vitamin_B6__and_Vitamin_B12_Supplementation_on_Fracture_Risk_in_Women:_A_Randomized_Controlled_Trial_ L2 - https://doi.org/10.1002/jbmr.3229 DB - PRIME DP - Unbound Medicine ER -