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Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

NCT00877227 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2009-05-06

No results posted yet for this study

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.

Conditions

  • Mild Hyperhomocysteinemia

Interventions

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.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Henk Blom, Dr · Amsterdam UMC, location VUmc

  • Marije Hogeveen, MD · Radboud University Medical Center Nijmegen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2003-11-30
Completion
2003-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00877227 on ClinicalTrials.gov