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Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00877227
First Posted: April 7, 2009
Last Update Posted: May 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Principal Investigator: Marije Hogeveen, MD Radboud University Medical Center Nijmegen
  More Information

Responsible Party: Dr H Blom, clinical biochemical geneticist, Metabolic Unit
ClinicalTrials.gov Identifier: NCT00877227     History of Changes
Other Study ID Numbers: 0010-0237
First Submitted: April 6, 2009
First Posted: April 7, 2009
Last Update Posted: May 6, 2009
Last Verified: April 2009

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

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