Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00877227
First received: April 6, 2009
Last updated: May 5, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Mild Hyperhomocysteinemia
Drug: 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • lowering total homocysteine concentrations [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: January 2003
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: folinic acid
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
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.
Other Name: folinic acid
No Intervention: 2
control subjects admitted at the Neonatal Intensive Care Unit (NICU)

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.

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • admitted at our NICU

Exclusion Criteria:

  • midline defects
  • Extracorporeal membrane oxygenation (ECMO) treatment
  • blood transfusion
  • overt renal failure
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00877227

Locations
Netherlands
Radboud University Medical center Nijmegen
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Investigators
Study Chair: Henk Blom, Dr VU University Medical Center Amsterdam
Principal Investigator: Marije Hogeveen, MD Radboud University Medical Center Nijmegen
  More Information

No publications provided

Responsible Party: Dr H Blom, clinical biochemical geneticist, Metabolic Unit
ClinicalTrials.gov Identifier: NCT00877227     History of Changes
Other Study ID Numbers: 0010-0237
Study First Received: April 6, 2009
Last Updated: May 5, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
CVA
stroke
newborns
homocysteine
folinic acid

Additional relevant MeSH terms:
Hyperhomocysteinemia
Amino Acid Metabolism, Inborn Errors
Avitaminosis
Deficiency Diseases
Genetic Diseases, Inborn
Malabsorption Syndromes
Malnutrition
Metabolic Diseases
Metabolism, Inborn Errors
Nutrition Disorders
Vitamin B Deficiency
Folic Acid
Formyltetrahydrofolates
Leucovorin
Levoleucovorin
Antidotes
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014