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Efficacy and Safety of Ultrahigh-Dose Methylcobalamin in Early-Stage Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial
Plain-language guide to PMID 35532908 (2022): double-blind randomized controlled trial study of Cyanocobalamin (Vitamin B12).
Key Facts
- PMID
- 35532908
- Journal
- JAMA neurology
- Year
- 2022
- Study type
- Randomized Controlled Trial
- Authors
- Oki R et al. (49 authors)
- DOI
- 10.1001/jamaneurol.2022.0901
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at Cyanocobalamin (Vitamin B12).
Who Took Part
PubMed indexes the participants as middle-aged adults, men only.
Patients were recruited from 25 neurology centers in Japan; those with ALS diagnosed within 1 year of onset by the updated Awaji criteria were initially enrolled.
The target participant number was 64 in both the methylcobalamin and placebo groups.
How the Study Was Run
The design is described as randomized, double-blind, placebo-controlled and multicenter.
The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.
Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.
The comparison arm used a placebo, so changes seen with Cyanocobalamin (Vitamin B12) could be set against what happens without it.
Running at several centres spread the Cyanocobalamin (Vitamin B12) study over different clinics and patient groups.
The timeline in the abstract includes 1 year.
This was a multicenter, placebo-controlled, double-blind, randomized phase 3 clinical trial with a 12-week observation and 16-week randomized period, conducted from October 17, 2017, to September 30, 2019.
Patients were randomly assigned through an electronic web-response system to methylcobalamin or placebo.
What Was Measured
PubMed files the paper under topics including Amyotrophic Lateral Sclerosis, Vital Capacity 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) over 1 year.
Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.
The publication is from 2022 (JAMA neurology), a journal based in United States.
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.