Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns - Full Text View

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:

Genetics Home Reference related topics: argininosuccinic aciduria citrullinemia N-acetylglutamate synthase deficiency ornithine translocase deficiency

MedlinePlus related topics: B Vitamins

Drug Information available for: Folic acid Leucovorin calcium Vitamin B Complex Levoleucovorin

U.S. FDA Resources

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)

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

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
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Formyltetrahydrofolates
Leucovorin

Folic Acid
Levoleucovorin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013