A Phase 1 interventional study of 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv) in Mild Hyperhomocysteinemia, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged Up to 2 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-05-06.
Sponsored by Radboud University Medical Center · Phase 1, Interventional, and Basic science
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.
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.
Exclusion Criteria:
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)
control subjects admitted at the Neonatal Intensive Care Unit (NICU)
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.
Also known as: folinic acid
lowering total homocysteine concentrations
Time frame: 2 weeks
This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center