Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

Phase 1

Completed

• Conditions: Mild Hyperhomocysteinemia
• Interventions: Drug: 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)

• Registration Number: NCT00877227
• Lead Sponsor: Radboud University Medical Center

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.

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 Timeline

• Study Start: 2003-01
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Status Verified: 2009-04
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Last Update Submitted: 2009-05-05
• Last Update Posted: 2009-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• admitted at our NICU

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
folinic acid	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

Primary Outcome Measures

Name	Time	Method
lowering total homocysteine concentrations	2 weeks

Trial Locations

Locations (1)

Radboud University Medical center Nijmegen; 🇳🇱 Nijmegen, Netherlands