Biochemical Cobalamin Status Clinical Trial
Official title:
B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Basic Science