CompletedNot Applicable

Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development

Norway107 participantsStarted 2004-12

Plain-language summary

Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life. The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

Who can participate

Age range

4 Weeks – 4 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 6 weeks old infants * The infant should be healthy and not have any serious malformations * The mother should be healthy and not have any serious disorders or use any daily medications * The mother should have an ordinary omnivorous diet Exclusion Criteria: * If there are evidence of serious infant disease during the study period, the infant should be excluded from the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA

Timeframe: Infant age 6 weeks - 4 months

Trial details

NCT IDNCT00479479

SponsorHaukeland University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-08

View on ClinicalTrials.gov More Vitamin B 12 Deficiency trials