Early Infant Micronutrition and Development
Launched by SYKEHUSET INNLANDET HF · Aug 11, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lillehammer, , Norway
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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