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Early Infant Micronutrition and Development

RecruitingPhase 2, Phase 3Ages 1 Month - 2 MonthsAllSykehuset Innlandet HF
NCT05005897 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. Poor status is also seen in affluent countries such as in Norway. Vitamin B12 is crucial for normal cell division and differentiation and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation infants on neurodevelopment. We also aim to measure the impact of B12 supplementation on several other outcomes. Study design: Individually randomized double-blind placebo-controlled trial breastfed infants who will be assigned to a screening group (in which measurements will be obtained immediately) or a control group (in which serum will be stored and measurements done after one year). Pregnant women will be informed about the stu

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Availability of informed verbal consent 2. Plan to reside in the defined study area for the next 12 months 3. Mothers intend to breastfeed their children for at least 8 months, and exclusively for 4 months Exclusion Criteria: 1. Severe systemic illness requiring hospitalization 2. Growth retardation 3. Severe congenital malformations 4. Plasma cobalamin concentration \<148 pmol/L (These children will be treated for vitamin B12 deficiency and not included in the RCT, but will be included in the cohort design)
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What it tests

  • Cyanocobalamin
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Where

1 site
Innlandet Hospital Trust
Lillehammer, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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