Supplementing infants with vitamin B12 to improve development
Vitamin B12 Status in Infancy and the Effect of Providing Vitamin B12 to Infants With Signs of Suboptimal Vitamin B12 Status - a Registry-based, Randomized Controlled Trial
This study is testing if giving breastfed infants daily vitamin B12 can help them grow and develop better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 1 Month to 2 Months |
| Sex | All |
| Sponsor | Sykehuset Innlandet HF Academic / other |
| Locations | 1 site (Lillehammer) |
| Trial ID | NCT05005897 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are breastfed infants whose mothers plan to exclusively breastfeed for at least four months.
Not a fit: Patients who have severe systemic illnesses, growth retardation, or congenital malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance neurodevelopmental outcomes in infants with vitamin B12 deficiency.
How similar studies have performed: Other studies have shown promising results with vitamin supplementation in infants, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lillehammer
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.