Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00877227

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Hyperhomocysteinemia	Drug: 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Nov 1, 2003

Actual Study Completion Date :

Nov 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: folinic acid 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) 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. Other Names: folinic acid
No Intervention: 2 control subjects admitted at the Neonatal Intensive Care Unit (NICU)

Arm

Intervention/Treatment

Experimental: folinic acid

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)

Other Names:

folinic acid

No Intervention: 2

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