Trial reportCalcified tissue international2016
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.
Trial report in Calcified tissue international, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.
- Beta-blocker use and fall risk in older individuals: Original results from two studies with meta-analysis.British journal of clinical pharmacology · 2017Pooled it
- The Impact of Nutritional Supplements on Sarcopenia: A Systematic Review and Meta-Analysis.Cureus · 2025Review
- Vitamin B12 status and skeletal muscle function among elderly: A literature review and pilot study on the effect of oral vitamin B12 supplementation in improving muscle function.Aging medicine (Milton (N.S.W)) · 2024Article
- The role of plasma concentrations and drug characteristics of beta-blockers in fall risk of older persons.Pharmacology research & perspectives · 2023Article
- Association of vitamins B12 and D3 with Balance and Falls in a sample of Greek older people.Journal of musculoskeletal & neuronal interactions · 2023Article
- Sarcopenia in chronic kidney disease: from bench to bedside.The Korean journal of internal medicine · 2023Review
- Associations between Serum Folate Concentrations and Functional Disability in Older Adults.Antioxidants (Basel, Switzerland) · 2023Article
- Relationship between hyperhomocysteinemia and coexisting obesity with low skeletal muscle mass in asymptomatic adult population.Scientific reports · 2022Article
- Risk factors for high fall risk in elderly patients with chronic kidney disease.International urology and nephrology · 2022Article
- Causal effects of homocysteine levels on the components of sarcopenia: A two-sample mendelian randomization study.Frontiers in genetics · 2022Article
- Association of vitamin and/or nutritional supplements with fall among patients with diabetes: A prospective study based on ACCORD and UK Biobank.Frontiers in nutrition · 2022Article
- Article
- A Propensity Score Matched Approach to Assess the Associations of Commonly Prescribed Medications with Fall Risk in a Large Harmonized Cohort of Older Ambulatory Persons.Drugs & aging · 2021Article
- Perspective: Practical Approach to Preventing Subclinical B12 Deficiency in Elderly Population.Nutrients · 2021Review
- Article
- Homocysteine: Its Possible Emerging Role in At-Risk Population Groups.International journal of molecular sciences · 2020Review
- Relationship between Homocysteine and Muscle Strength Decline: The Baltimore Longitudinal Study of Aging.The journals of gerontology. Series A, Biological sciences and medical sciences · 2018Article
- Vitamin B12 deficiency and impaired expression of amnionless during aging.Journal of cachexia, sarcopenia and muscle · 2018Article
- Role of Water Soluble Vitamins in the Reduction Diet of an Amateur Sportsman.Open life sciences · 2018Article
- Vitamin B12 and Homocysteine Associations with Gait Speed in Older Adults: The Baltimore Longitudinal Study of Aging.The journal of nutrition, health & aging · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Elevated homocysteine concentrations are associated with a decline in physical function in elderly persons. Homocysteine-lowering therapy may slow down this decline. This study aimed to examine the effect of a 2-year intervention of vitamin B12 and folic acid supplementation on physical performance, handgrip strength, and risk of falling in elderly subjects in a double-blind, randomized placebo-controlled trial. Participants aged ≥65 years with elevated plasma homocysteine concentrations [12-50 µmol/L (n = 2919)] were randomly assigned to daily supplementation of 500 µg vitamin B12, 400 µg folic acid, and 600 IU vitamin D3, or to placebo with 600 IU vitamin D3. Physical performance (range 0-12) and handgrip strength (kg) were measured at baseline and after 2 years. Falls were reported prospectively on a research calendar. Intention-to-treat (primary) and per-protocol (secondary) analyses were performed. Physical performance level and handgrip strength significantly decreased during the follow-up period, but this decline did not differ between groups. Moreover, time to first fall was not significantly different (HR: 1.0, 95% CI 0.9-1.2). Secondary analyses on a per-protocol base identified an interaction effect with age on physical performance. In addition, the treatment was associated with higher follow-up scores on the walking test (cumulative OR: 1.3, 95% CI 1.1-1.5). Two-year supplementation of vitamin B12 and folic acid was neither effective in reducing the age-related decline in physical performance and handgrip strength, nor in the prevention of falling in elderly persons. Despite the overall null-effect, the results provide indications for a positive effect of the intervention on gait, as well as on physical performance among compliant persons >80 years. These effects should be further tested in future studies.
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