Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

Mild Hyperhomocysteinemia Clinical Trial

Official title:

Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877227
• Other study ID #: 0010-0237
• Status: Completed
• Phase: Phase 1
• First received: April 6, 2009
• Last updated: May 5, 2009
• Start date: January 2003
• Est. completion date: November 2003

Study information

• Verified date: April 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Weeks

Eligibility

Inclusion Criteria:

• admitted at our NICU

Exclusion Criteria:

• midline defects

• Extracorporeal membrane oxygenation (ECMO) treatment

• blood transfusion

• overt renal failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperhomocysteinemia
• Mild Hyperhomocysteinemia

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical center Nijmegen	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lowering total homocysteine concentrations		2 weeks	No