Supplementing infants with vitamin B12 to improve development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of daily oral vitamin B12 supplementation in breastfed infants to assess its impact on neurodevelopment and other health outcomes. It is designed as an individually randomized double-blind placebo-controlled trial, where infants will be assigned to either a screening group or a control group. The screening group will receive immediate measurements, while the control group will have their serum stored for analysis after one year. The study aims to address the common issue of vitamin B12 deficiency and its implications for infant growth and development.

Why it matters

Who can join: the full rules

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)

Where it's running

• Innlandet Hospital Trust
  Lillehammer, Norway Recruiting

Study contacts

• Principal investigator: Tor A Strand, M.D. / Ph.D. — Sykehuset Innlandet HF
• Study coordinator: Carolien Konijnenberg, Ph.D
• Email: carolien.konijnenberg@inn.no
• Phone: +47 61 28 74 94

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.