Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00877227

Enrollment

Registered

2009-04-07

Start date

2003-01-31

Completion date

2003-11-30

Last updated

2009-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Hyperhomocysteinemia

Keywords

CVA, stroke, newborns, homocysteine, folinic acid

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.

Interventions

DRUG5-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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Weeks

Healthy volunteers

Yes

Inclusion criteria

* admitted at our NICU

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
lowering total homocysteine concentrations	2 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026