Vitamin B 12 Deficiency Clinical Trial
Official title:
Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
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.
During fetal life and infancy, an adequate cobalamin status is important for normal growth
and central nervous system development. A metabolic profile consistent with impaired
cobalamin status is prevalent in breast-fed infants. Whether this profile reflects immature
organ systems or cobalamin deficiency has not been clarified.
Low levels of cobalamin, elevated levels of total homocysteine (tHcy), cystathionine and/or
methylmalonic acid (MMA) in the blood are measures of impaired cobalamin status.
The purpose of this randomized, controlled study is to determine if cobalamin
supplementation may influence the metabolic profile related to cobalamin status in infants.
Six weeks old infants will be randomly assigned to receive either an intramuscular injection
with 400 µg cobalamin or no intervention. Concentrations of cobalamin and folate in serum,
and total homocysteine (tHcy), methylmalonic acid (MMA) and cystathionine in plasma will be
determined at inclusion and at the age of 4 months. A questionnaire on infant and maternal
nutrition, vitamin supplementation, growth parameters, parity and maternal use of tobacco
will be completed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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