Abstract
In the initial B-proof, we found inconsistent results of B vitamin supplementation. However, the debate regarding the effects of B vitamins on age-related diseases continues. Therefore, our aim was to investigate the long-term effects (5-7 years follow-up) of an intervention with folic acid and vitamin-B12 supplementation on fracture and cardiovascular disease risk. Extended follow-up of the B-PROOF trial, a multi-center, double-blind randomized placebo-controlled trial designed to assess the effect of 2-3 years daily supplementation with folic acid (400μg) and vitamin-B12 (500μg) versus placebo (n=2,919). Primary outcome was verified self-reported fracture incidence and secondary outcomes were self-reported cardiovascular endpoints, which were collected through a follow-up questionnaires Proportional hazard analyses was used for the effect of the intervention on risk of fracture(s) and logistic regression for the effect of the intervention on risk of cardiovascular disease. A total of 1,298 individuals (44.5%) participated in the second follow-up round with median of 54 months [51-58], (n=662 and n=636, treatment versus placebo group). Median age at baseline was 71.0 years [68.0-76.0] for both groups. No effect was observed of the intervention on osteoporotic fracture or any fracture risk after a follow-up (HR: 0.99, 95% CI: 0.62-1.59 and HR: 0.77; 95% CI: 0.50-1.19, respectively), nor on cardiovascular or cerebrovascular disease risk (OR: 1.05; 95%CI: 0.80-1.44 and OR: 0.85; 95%CI: 0.50-1.45, respectively). Potential interaction by baseline homocysteine concentration was observed for osteoporotic- and any fracture (p=0.10 and 0.06 respectively), which indicated a significantly lower risk of any fracture in the treatment group with higher total homocysteine concentrations (>15.1μmol/l). No age-dependent effects were present. This study supports and extends previous null-findings of the B-PROOF trial and shows that supplementation of folic acid and vitamin-B12 has no effect on fracture risk, nor on cardiovascular disease in older individuals over a longer follow-up period. However, B-vitamin supplementation may be beneficial in reducing fractures in individuals with high total homocysteine concentrations, a finding which needs to be replicated.
Highlights
Homocysteine-lowering therapy has been suggested as a potential treatment option for common diseases such as osteoporosis and cardiovascular disease [1]
Within the older BPROOF population, we observed no effect of B-vitamin intervention on the overall incidence of coronary heart disease, but a significantly but slightly lower risk of cerebrovascular events was observed among females
In 2015, we extended the follow-up of the original B-vitamins for the Prevention Of Osteoporotic Fractures (B-PROOF) study by sending the participants who gave permission to contact them additional questionnaires to investigate the longterm effect of the intervention on risk of cancer, fracture and cardiovascular diseases (n 1⁄4 1,298)
Summary
Homocysteine-lowering therapy has been suggested as a potential treatment option for common diseases such as osteoporosis and cardiovascular disease [1]. Within the older BPROOF population, we observed no effect of B-vitamin intervention on the overall incidence of coronary heart disease, but a significantly but slightly lower risk of cerebrovascular events was observed among females. This was further confirmed by a recent meta-analysis that showed a reduced risk of stroke with folic acid alone and B-complex supplementation [5]. Our aim was to investigate the long-term effects (5e7 years follow-up) of an intervention with folic acid and vitamin-B12 supplementation on fracture and cardiovascular disease risk.
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