Vitamin B
Developmental neurology & neurodisability
EPIDEMIOLOGY
NUTRITION & DIETETICS
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
20 04 2023
20 04 2023
Historique:
medline:
24
4
2023
pubmed:
21
4
2023
entrez:
20
04
2023
Statut:
epublish
Résumé
Vitamin B Infant blood samples, collected at public healthcare clinics, are analysed for plasma cobalamin levels. Infants with plasma cobalamin <148 pmol/L are immediately treated with hydroxocobalamin and excluded from the RCT. Remaining infants (cobalamin ≥148 pmol/L) are randomly assigned (in a 1:1 ratio) to either a screening or a control group. In the screening group, baseline samples are immediately analysed for total homocysteine (tHcy), while in the control group, the baseline samples will be analysed after 12 months. Screening group infants with plasma tHcy >6.5 µmol/L, are given an intramuscular injection of hydroxocobalamin (400 µg). The primary outcomes are cognitive, language and motor development assessed using the Bayley Scales of Infant and Toddler Development at 12 months of age. The study has been approved by the Regional Committee for Medical and Health Research Ethics (ref: 186505). Investigators who meet the Vancouver requirements will be eligible for authorship and be responsible for dissemination of study findings. Results will extend current knowledge on consequences of subclinical vitamin B NCT05005897.
Identifiants
pubmed: 37080624
pii: bmjopen-2022-069102
doi: 10.1136/bmjopen-2022-069102
pmc: PMC10124272
doi:
Substances chimiques
Vitamin B 12
P6YC3EG204
Hydroxocobalamin
Q40X8H422O
Vitamins
0
Banques de données
ClinicalTrials.gov
['NCT05005897']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e069102Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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