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Search / Trial NCT05005897

Early Infant Micronutrition and Development

Launched by SYKEHUSET INNLANDET HF · Aug 11, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Nutrition Vitamins Breastfeeding Infant Neurodevelopment Growth Clinical Trial

ClinConnect Summary

This clinical trial, called "Early Infant Micronutrition and Development," is studying how daily vitamin B12 supplements can help improve the growth and brain development of infants. Vitamin B12 is important for babies because it helps their bodies grow and their brains develop properly. The researchers want to see if giving vitamin B12 to breastfed infants who may be deficient can make a difference in their growth and brain function at 12 months of age.

If you are a pregnant woman living in the study area and plan to breastfeed your baby for at least eight months, you might be eligible to participate. You will first hear about the study during your first check-up and will have the chance to join after your baby is born. In the trial, some infants will receive vitamin B12 supplements while others will not, and researchers will compare the two groups to see how the supplements affect growth and development. It’s a great opportunity to contribute to important research that could help improve infant health!

Gender

ALL

Eligibility criteria

  • 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)

About Sykehuset Innlandet Hf

Sykehuset Innlandet HF is a prominent healthcare provider in Norway, dedicated to delivering high-quality medical services and advancing clinical research. As a key player in the region's healthcare landscape, the organization operates several hospitals and specialized units, focusing on a wide range of medical disciplines. Sykehuset Innlandet HF is committed to fostering innovative clinical trials that enhance patient care and contribute to the development of new therapies. With a strong emphasis on collaboration and ethical standards, the organization seeks to improve health outcomes through rigorous research and evidence-based practices.

Locations

Lillehammer, , Norway

Patients applied

0 patients applied

Trial Officials

Tor A Strand, M.D. / Ph.D.

Principal Investigator

Sykehuset Innlandet HF

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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