Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

Radboud University Medical Center

Status and phase: Completed; Phase 1

Conditions: Mild Hyperhomocysteinemia

Treatments: Drug: 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)

Study type: Interventional

Funder types: Other

Identifiers

NCT00877227

0010-0237

Details and patient eligibility

About

The purpose of this study is to determine whether supplementation with folinic acid, a B vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. These increased concentrations can easily and safely be lowered by folic acid in adults.

Full description

The incidence of cerebrovascular accidents (CVA) occurring perinatally is relatively high and aspects of the multifactorial pathophysiology remain unclear. Elevated homocysteine concentrations are shown to be associated with an increased risk for CVA in newborns. We want to study the possible homocysteine lowering effect of folinic acid in newborns.

We will include newborns in our prospective randomized folinic acid intervention study from patients admitted to our Neonatal Intensive Care Unit. We will measure total homocysteine (tHcy) and folate concentrations at three time points. The intervention group will be treated with folinic acid (70 µg/kg/day) for two weeks.

Enrollment: 37 patients

Sex: All

Ages: Under 2 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• admitted at our NICU

Exclusion criteria

• midline defects
• Extracorporeal membrane oxygenation (ECMO) treatment
• blood transfusion
• overt renal failure

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

folinic acid

Experimental group

Description:

Folinic acid was given for two weeks as 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv). This solution was administered either intravenously (first week) or orally. To lower homocysteine in adults 5 mg/day folic acid is frequently used. Using an average bodyweight of 70 kg for adults we calculated a daily dose of 70 microgram/kg/day for our newborns

Treatment:

Drug: 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)

2

No Intervention group

Description:

control subjects admitted at the Neonatal Intensive Care Unit (NICU)