Biochemical Cobalamin Status Clinical Trial
Official title:
B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS
| Verified date | September 2010 |
| Source | Haukeland University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Norway: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | August 2010 |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 5 Months to 7 Months |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Norway | Haukeland University Hospital | Bergen |
| Lead Sponsor | Collaborator |
|---|---|
| Haukeland University Hospital |
Norway,
Bjørke-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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Maternal evaluation of changes in infant behaviour/development | 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 | 4 weeks | No |