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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
Plain-language guide to PMID 22136481 (2011): double-blind randomized controlled trial of Cyanocobalamin (Vitamin B12) in 2919 subjects.
Key Facts
- PMID
- 22136481
- Journal
- BMC geriatrics
- Year
- 2011
- Study type
- Randomized Controlled Trial
- Authors
- van Wijngaarden JP et al. (14 authors)
- DOI
- 10.1186/1471-2318-11-80
What This Study Did, in Plain Language
What Was Tested
Researchers studied Cyanocobalamin (Vitamin B12) in this randomized controlled trial publication.
The B-PROOF study is registered with the Netherlands Trial (NTR NTR1333) and with ClinicalTrials.gov (NCT00696514).
Who Took Part
According to the abstract, 2919 subjects were involved.
By PubMed's age tags, the people studied were older adults and people over 80, both men and women.
How the Study Was Run
The design is described as randomized, double-blind and placebo-controlled.
Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Blinding on both sides kept the subjects and researchers unaware of who received Cyanocobalamin (Vitamin B12).
A placebo (an inactive look-alike) gave the Cyanocobalamin (Vitamin B12) group a baseline to be compared against.
The primary outcome of the study is osteoporotic fractures.
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.
What Was Measured
Topics PubMed links to this paper include Dietary Supplements, Folic Acid, Fractures, Bone, Incidence, Osteoporosis and Vitamin B 12.
What This Means in Plain Language
The paper is a randomized, double-blind and placebo-controlled study of Cyanocobalamin (Vitamin B12) in 2919 subjects.
With several hundred people or more, it is a fairly large study for this kind of research.
Results are reported in around 3 sentences of the abstract; we leave them to the paper itself rather than summarise them.
The publication is from 2011 (BMC geriatrics), a journal based in England.
More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.
Our Notes on the Compound
Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.