Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns

Conditions
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Mild Hyperhomocysteinemia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admitted at our NICU Exclusion Criteria: midline defects Extracorporeal membrane oxygenation (ECMO) treatment blood transfusion overt renal failure

Ages Eligible for Study
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Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: folinic acid<br>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 | Drug: 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)<br>* 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.<br>* Other names: folinic acid;|
| No Intervention: 2<br>control subjects admitted at the Neonatal Intensive Care Unit (NICU) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lowering total homocysteine concentrations |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CVA, stroke, newborns, homocysteine, folinic acid