CompletedNot Applicable

Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development

Norway107 participantsStarted 2004-12

Plain-language summary

Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life. The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

Who can participate

Age range4 Weeks – 4 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 6 weeks old infants * The infant should be healthy and not have any serious malformations * The mother should be healthy and not have any serious disorders or use any daily medications * The mother should have an ordinary omnivorous diet Exclusion Criteria: * If there are evidence of serious infant disease during the study period, the infant should be excluded from the study

What they're measuring

Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA

Timeframe: Infant age 6 weeks - 4 months

Trial details

NCT IDNCT00479479

SponsorHaukeland University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-08

View on ClinicalTrials.gov More Vitamin B 12 Deficiency trials