Biochemical Cobalamin Status, Motor Neurodevelopment
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHydroxycobalamin
Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection
DIETARY_SUPPLEMENTSham injection
needle injection without any substance given
Sponsors
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Months to 7 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Norway
Outcome results
None listed