NCT01201005

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

B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 5 Months – 7 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hydroxycobalamin	Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection
DIETARY_SUPPLEMENT	Sham injection	needle injection without any substance given

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-09-14
• Last updated: 2010-09-14

Locations

1 site across 1 country: Norway