Trial reportBMC geriatrics2011
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.
Trial report in BMC geriatrics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00696514 (Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People), which is not on this map. Cited by 49 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People
Who cites it
49 citing papers in PubMed, 4 syntheses or guidelines pooled it, 94 citations in OpenAlex.
- Meta-analysis of genome-wide association studies of aggressive and chronic periodontitis identifies two novel risk loci.European journal of human genetics : EJHG · 2019Pooled it
- Genome-wide association meta-analysis of coronary artery disease and periodontitis reveals a novel shared risk locus.Scientific reports · 2018Pooled it
- Beta-blocker use and fall risk in older individuals: Original results from two studies with meta-analysis.British journal of clinical pharmacology · 2017Pooled it
- Homocysteine-lowering interventions for preventing cardiovascular events.The Cochrane database of systematic reviews · 2017Pooled it
- Trial
- DHA status influences effects of B-vitamin supplementation on cognitive ageing: a post-hoc analysis of the B-proof trial.European journal of nutrition · 2022Trial
- B-vitamins and body composition: integrating observational and experimental evidence from the B-PROOF study.European journal of nutrition · 2020Trial
- Folate and Vitamin BNutrients · 2016Trial
- Effects of Two-Year Vitamin BNutrients · 2016Trial
- A Randomized Controlled Trial to Examine the Effect of 2-Year Vitamin B12 and Folic Acid Supplementation on Physical Performance, Strength, and Falling: Additional Findings from the B-PROOF Study.Calcified tissue international · 2016Trial
- Dietary Sources of Vitamin B-12 and Their Association with Vitamin B-12 Status Markers in Healthy Older Adults in the B-PROOF Study.Nutrients · 2015Trial
- Effect of Vitamin B12 and Folic Acid Supplementation on Bone Mineral Density and Quantitative Ultrasound Parameters in Older People with an Elevated Plasma Homocysteine Level: B-PROOF, a Randomized Controlled Trial.Calcified tissue international · 2015Trial
- Effect of folic acid on bone metabolism: a randomized double blind clinical trial in postmenopausal osteoporotic women.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2014Trial
- The effect of homocysteine-lowering with B-vitamins on osteoporotic fractures in patients with cerebrovascular disease: substudy of VITATOPS, a randomised placebo-controlled trial.BMC geriatrics · 2013Trial
- Homocysteine and the methylenetetrahydrofolate reductase 677C-->T polymorphism in relation to muscle mass and strength, physical performance and postural sway.European journal of clinical nutrition · 2013Trial
- The association between hyperkyphosis and physical function in geriatric outpatients with frailty.Archives of osteoporosis · 2026Article
- The association between adherence to the EAT-Lancet diet and cognitive ageing.Age and ageing · 2024Article
- The role of plasma concentrations and drug characteristics of beta-blockers in fall risk of older persons.Pharmacology research & perspectives · 2023Article
- The association between adherence to a plant-based diet and cognitive ageing.European journal of nutrition · 2023Article
- Vitamin D, Folic Acid and Vitamin BNutrients · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOsteoporosis 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/
designThe 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. DISCUSSION: 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.
trial registrationThe B-PROOF study is registered with the Netherlands Trial (NTR NTR1333) and with ClinicalTrials.gov (NCT00696514).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.