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Sponsors and Collaborators: |
Haukeland University Hospital Norwegian Foundation for Health and Rehabilitation The Foundation to promote research into functional vitamin B12-deficiency |
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Information provided by: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT00479479 |
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.
Condition | Intervention |
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Vitamin B 12 Deficiency |
Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development |
Enrollment: | 107 |
Study Start Date: | December 2004 |
Study Completion Date: | December 2006 |
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.
Ages Eligible for Study: | up to 4 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital | |
Bergen, Norway, 5018 |
Principal Investigator: | Anne-Lise Bjørke Monsen, M.D., Ph.D. | Haukeland University Hospital |
Study ID Numbers: | 16941 |
Study First Received: | May 25, 2007 |
Last Updated: | May 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00479479 History of Changes |
Health Authority: | Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway |
cobalamin methylmalonic acid homocysteine folate newborns |
infants Deficiency Disease Breastfeeding Infant |
Vitamin B Complex Avitaminosis Hematinics Hydroxocobalamin Vitamin B 12 Deficiency Vitamin B 12 Trace Elements |
Folic Acid Malnutrition Vitamins Nutrition Disorders Micronutrients Deficiency Diseases |
Vitamin B Complex Vitamin B Deficiency Hematinics Avitaminosis Growth Substances Hematologic Agents Hydroxocobalamin Physiological Effects of Drugs Vitamin B 12 Deficiency |
Vitamin B 12 Pharmacologic Actions Malnutrition Therapeutic Uses Vitamins Nutrition Disorders Micronutrients Deficiency Diseases |