An interventional study of 13C5-labelled 5-methyltetrahydrofolic acid in Healthy, sponsored by Quadram Institute Bioscience. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-18.
Sponsored by Quadram Institute Bioscience · Not applicable, Interventional, and Basic science
The aim of this study is to calculate the plasma apparent volume of distribution of natural folate to give a more accurate value for use in a mathematical model of apparent folate absorption.
Bioavailability is a major determinant of nutritional status. In order to determine a safe level of folate fortification, its bioavailability must be assessed, so that risk-benefit analysis can be carried out. Recently, a mathematical model of folate true absorption which takes into account the liver first pass was devised (ref 1). In this model, the volume of distribution is a convenient method for describing how well a nutrient is removed from plasma and distributed into tissues.
In this study, volume of distribution will be more accurately estimated using an intravenous dose of labelled (13C5) dose of natural folate (5-methyltetrahydrofolic acid) in healthy adults aged 18-65, over a wide body mass index (BMI) range.
Healthy adults will be given an IV dose of a small amount of 13C5 5-methyltetrahydrofolic acid, and blood samples will be taken at regular time points via a cannula over a 2hr time period.
The primary objective is to estimate the sampled plasma pool volume of distribution in order to quantify the fraction of any folate test dose, or folate metabolites, appearing in systemic plasma circulation in future studies of bioavailability.
Quadram Institute Bioscience is the lead sponsor of 42 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
IV test dose of 13C5-labelled 5-methyltetrahydrofolic acid to all eligible volunteers, followed by regular blood samplings over 2hr period taken via a cannula.
Dietary Supplement: 13C5-labelled 5-methyltetrahydrofolic acid
one intravenous bolus dose of no more than 500nmole 13C5-labelled 5-methyltetrahydrofolic acid, followed by multiple blood samplings at regular time intervals. Total 2hr "intervention".
Also known as: 13C5-labelled 5 methyltetrahydrofolic acid, calcium salt, 6S-5-CH3-H4-Pte[13C5] Glu-Ca
Estimation of sampled plasma pool volume of distribution for natural folates
Time frame: 2 hours
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Quadram Institute Bioscience