Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

NCT ID: NCT00877227

Last Updated: 2009-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2003-11-30

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.

Conditions

Mild Hyperhomocysteinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

2

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

folinic acid

Eligibility Criteria

Inclusion Criteria

• admitted at our NICU

Exclusion Criteria

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

• Maximum Eligible Age: 2 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Metabolic Unit

Principal Investigators

Henk Blom, Dr

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Marije Hogeveen, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center Nijmegen

Locations

Radboud University Medical center Nijmegen

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

0010-0237

Identifier Type: -

Identifier Source: org_study_id