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Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

Primary Purpose

Mild Hyperhomocysteinemia

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Hyperhomocysteinemia focused on measuring CVA, stroke, newborns, homocysteine, folinic acid

Eligibility Criteria

undefined - 2 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • admitted at our NICU

Exclusion Criteria:

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

Sites / Locations

  • Radboud University Medical center Nijmegen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

folinic acid

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

lowering total homocysteine concentrations

Secondary Outcome Measures

Full Information

First Posted
April 6, 2009
Last Updated
May 5, 2009
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00877227
Brief Title
Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns
Official Title
Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Hyperhomocysteinemia
Keywords
CVA, stroke, newborns, homocysteine, folinic acid

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
folinic acid
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
No Intervention
Arm Description
control subjects admitted at the Neonatal Intensive Care Unit (NICU)
Intervention Type
Drug
Intervention Name(s)
5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)
Other Intervention Name(s)
folinic acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
lowering total homocysteine concentrations
Time Frame
2 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: admitted at our NICU Exclusion Criteria: midline defects Extracorporeal membrane oxygenation (ECMO) treatment blood transfusion overt renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henk Blom, Dr
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marije Hogeveen, MD
Organizational Affiliation
Radboud University Medical Center Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical center Nijmegen
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands

12. IPD Sharing Statement

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Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

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