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

NCT00479479 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2015-07-21

No results posted yet for this study

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.

Conditions

  • Vitamin B 12 Deficiency

Interventions

DRUG

Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)

Sponsors & Collaborators

  • Norwegian Foundation for Health and Rehabilitation

    collaborator OTHER

  • Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Anne-Lise Bjørke Monsen, M.D., Ph.D. · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-08-31
Completion
2006-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479479 on ClinicalTrials.gov