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

Haukeland University Hospital

Status: Completed

Conditions: Biochemical Cobalamin Status; Motor Neurodevelopment

Treatments: Dietary Supplement: Hydroxycobalamin; Dietary Supplement: Sham injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01201005

REK-Vest 104.08

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 5 to 7 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Hydroxycobalamin

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Hydroxycobalamin

needle injection

Sham Comparator group

Description:

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

Treatment:

Dietary Supplement: Sham injection