Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

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.

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Key information

Conditions

Mild Hyperhomocysteinemia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

Up to 2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Radboud University Medical center Nijmegen

Nijmegen, 6500HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

admitted at our NICU

Exclusion criteria

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

Treatment and study plan

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

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.

Other names: folinic acid

Primary outcomes

lowering total homocysteine concentrations

Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Apr 7, 2009
Registry last updated: May 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed