NCT00479479

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1.7 years

First QC Date

May 25, 2007

Last Update Submit

July 20, 2015

Conditions

Vitamin B 12 Deficiency

Keywords

cobalaminmethylmalonic acidhomocysteinefolatenewbornsinfantsDeficiency DiseaseBreastfeedingInfant

Outcome Measures

Primary Outcomes (1)

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

    Infant age 6 weeks - 4 months

Secondary Outcomes (1)

  • Outcome is related to changes in growth parameters; weight, length, head circumference

    Infant age: 6 weeks - 4 months

Study Arms (2)

Cobalamin

EXPERIMENTAL

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

Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

No intervention

NO INTERVENTION

No intervention

Interventions

Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)DRUG

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

Cobalamin

Eligibility Criteria

Age4 Weeks - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • If there are evidence of serious infant disease during the study period, the infant should be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital

Bergen, 5018, Norway

Location

Related Publications (5)

  • Bjorke Monsen AL, Ueland PM, Vollset SE, Guttormsen AB, Markestad T, Solheim E, Refsum H. Determinants of cobalamin status in newborns. Pediatrics. 2001 Sep;108(3):624-30. doi: 10.1542/peds.108.3.624.

    PMID: 11533328BACKGROUND

  • Monsen AL, Refsum H, Markestad T, Ueland PM. Cobalamin status and its biochemical markers methylmalonic acid and homocysteine in different age groups from 4 days to 19 years. Clin Chem. 2003 Dec;49(12):2067-75. doi: 10.1373/clinchem.2003.019869.

    PMID: 14633879BACKGROUND

  • Allen LH. Vitamin B12 metabolism and status during pregnancy, lactation and infancy. Adv Exp Med Biol. 1994;352:173-86. doi: 10.1007/978-1-4899-2575-6_14.

    PMID: 7832046BACKGROUND

  • Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.

    PMID: 9930566BACKGROUND

  • Bjorke-Monsen AL, Torsvik I, Saetran H, Markestad T, Ueland PM. Common metabolic profile in infants indicating impaired cobalamin status responds to cobalamin supplementation. Pediatrics. 2008 Jul;122(1):83-91. doi: 10.1542/peds.2007-2716.

    PMID: 18595990DERIVED

MeSH Terms

Conditions

Vitamin B 12 DeficiencyDeficiency DiseasesBreast Feeding

Interventions

Hydroxocobalamin

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisMalnutritionNutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Vitamin B 12CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Anne-Lise Bjørke Monsen, M.D., Ph.D.

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2007

First Posted

May 28, 2007

Study Start

December 1, 2004

Primary Completion

August 1, 2006

Study Completion

December 1, 2006

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

NO(1)