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

Not Applicable

Completed

• Conditions: Biochemical Cobalamin Status; Motor Neurodevelopment
• Interventions: Dietary Supplement: Hydroxycobalamin; Dietary Supplement: Sham injection

• Registration Number: NCT01201005
• Lead Sponsor: Haukeland University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-09
• Study First Submitted: 2010-09-12
• Study First Submitted QC: 2010-09-13
• Last Update Submitted: 2010-09-13
• Study First Posted: 2010-09-14
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxycobalamin	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
needle injection	Sham 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

Primary Outcome Measures

Name	Time	Method
Changes in biochemical status and neurodevelopment	4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Maternal evaluation of changes in infant behaviour/development	4 weeks	Maternal evaluation of changes in infant behaviour will be tested by using a maternal questionnaire, Ages and Stages (ASQ), a highly rated child screening and monitoring system, before and after intervention

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway