- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877227
Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns
Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Nijmegen, Netherlands, 6500HB
- Radboud University Medical Center Nijmegen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- admitted at our NICU
Exclusion Criteria:
- midline defects
- Extracorporeal membrane oxygenation (ECMO) treatment
- blood transfusion
- overt renal failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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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 Names:
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No Intervention: 2
control subjects admitted at the Neonatal Intensive Care Unit (NICU)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
lowering total homocysteine concentrations
Time Frame: 2 weeks
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2 weeks
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Collaborators and Investigators
Investigators
- Study Chair: Henk Blom, Dr, Amsterdam Umc, Location Vumc
- Principal Investigator: Marije Hogeveen, MD, Radboud University Medical Center Nijmegen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Nutrition Disorders
- Genetic Diseases, Inborn
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Metabolism, Inborn Errors
- Malabsorption Syndromes
- Amino Acid Metabolism, Inborn Errors
- Vitamin B Deficiency
- Hyperhomocysteinemia
- Physiological Effects of Drugs
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Leucovorin
- Levoleucovorin
- Formyltetrahydrofolates
Other Study ID Numbers
- 0010-0237
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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