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B Vitamin Status in Premature and Small for Gestational Age(SGA) Infants

NCT ID: NCT01201005

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-08-31

Brief Summary

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Premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. During the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months infants with biochemical signs of impaired cobalamin status (i.e.: tHcy \> 97.5 percentile for cobalamin treated infants, i.e.: tHcy\>6.5 µM/L) will be randomised to cobalamin treatment or placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo treatment according to infant biochemical status and neurodevelopment.

Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency will normalize biochemical status and cause improved motor neurodevelopment.

Detailed Description

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Conditions

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Biochemical Cobalamin Status Motor Neurodevelopment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Hydroxycobalamin

Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma) is given as a singel intramuscular injection.

The syringe is covered so it is impossible to see whether it contains any substance

Group Type ACTIVE_COMPARATOR

Hydroxycobalamin

Intervention Type DIETARY_SUPPLEMENT

Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection

needle injection

The controls receive an intramuscular "injection": which is merely an introduction of the needle into the muscle whithout any injection. The syringe is covered so it is not possible to see whether the syringe contains any substance

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type DIETARY_SUPPLEMENT

needle injection without any substance given

Interventions

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Hydroxycobalamin

Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection

Intervention Type DIETARY_SUPPLEMENT

Sham injection

needle injection without any substance given

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Birthweight \< 3000 grams
* Age 6 months (+/- 0.5 months)
* Plasma total homocysteine \> 6.5 umol/L

Exclusion Criteria

* Plasma total homocysteine \< 6.5 umol/L
Minimum Eligible Age

5 Months

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 18595990 (View on PubMed)

Torsvik IK, Ueland PM, Markestad T, Midttun O, Bjorke Monsen AL. Motor development related to duration of exclusive breastfeeding, B vitamin status and B12 supplementation in infants with a birth weight between 2000-3000 g, results from a randomized intervention trial. BMC Pediatr. 2015 Dec 18;15:218. doi: 10.1186/s12887-015-0533-2.

Reference Type DERIVED
PMID: 26678525 (View on PubMed)

Torsvik IK, Markestad T, Ueland PM, Nilsen RM, Midttun O, Bjorke Monsen AL. Evaluating iron status and the risk of anemia in young infants using erythrocyte parameters. Pediatr Res. 2013 Feb;73(2):214-20. doi: 10.1038/pr.2012.162. Epub 2012 Nov 20.

Reference Type DERIVED
PMID: 23168578 (View on PubMed)

Other Identifiers

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REK-Vest 104.08

Identifier Type: -

Identifier Source: org_study_id