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

NCT01201005 | Completed

• 1 other identifier: REK-Vest 104.08
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biochemical Cobalamin Status; Motor Neurodevelopment

Outcome Measures

Primary Outcomes (1)

• Changes in biochemical status and neurodevelopment

  Bloodsamples for analysis of B vitamin status are drawn before intervention and after 4 weeks Neurological evaluation (AIMS test) of the infants is done before intervention and after 4 weeks

  4 weeks

Secondary Outcomes (1)

• Maternal evaluation of changes in infant behaviour/development

  4 weeks

Study Arms (2)

Hydroxycobalamin

ACTIVE COMPARATOR

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

Dietary Supplement: Hydroxycobalamin

needle injection

SHAM COMPARATOR

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

Dietary Supplement: Sham injection

Interventions

Hydroxycobalamin DIETARY_SUPPLEMENT

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

Hydroxycobalamin

Sham injection DIETARY_SUPPLEMENT

needle injection without any substance given

needle injection

Eligibility Criteria

• Age: 5 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Plasma total homocysteine \< 6.5 umol/L

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (3)

• 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: 18595990 BACKGROUND

• 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.

  PMID: 26678525 DERIVED

• 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.

  PMID: 23168578 DERIVED

MeSH Terms

Interventions

Hydroxocobalamin; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Vitamin B 12; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2010
• First Posted: September 14, 2010
• Study Start: July 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

NO (1)