Estimation of Plasma Folate Apparent Volume of Distribution in Adults (FOLCAN)
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|ClinicalTrials.gov Identifier: NCT00975351|
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : February 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: 13C5-labelled 5-methyltetrahydrofolic acid||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Estimation of Plasma Folate Apparent Volume of Distribution in Adults|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2010|
Experimental: IV dose of 5-methyltetrahydrofolic acid
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".
- Estimation of sampled plasma pool volume of distribution for natural folates [ Time Frame: 2 hours ]
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): NCT00975351
|Institute of Food Research|
|Norwich, Norfolk, United Kingdom, NR4 6JF|
|Principal Investigator:||Paul Finglas||Quadram Institute|