FOLCAN: Estimation of Plasma Folate Apparent Volume of Distribution in Adults

Sponsor

Quadram Institute Bioscience (Other)

Overall Status

Completed

CT.gov ID

NCT00975351

Collaborator

University of Nottingham (Other)

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: 13C5-labelled 5-methyltetrahydrofolic acid	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

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 :

Jun 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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". Other Names: 13C5-labelled 5 methyltetrahydrofolic acid, calcium salt 6S-5-CH3-H4-Pte[13C5] Glu-Ca

Arm

Intervention/Treatment

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".

Other Names:

13C5-labelled 5 methyltetrahydrofolic acid, calcium salt

6S-5-CH3-H4-Pte[13C5] Glu-Ca

Outcome Measures

Primary Outcome Measures

Estimation of sampled plasma pool volume of distribution for natural folates [2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males and females
Aged 18-65
Body mass index above 19.5 and below 40
Smokers and non-smokers
Participation in the FolGene study

Exclusion Criteria:

Pregnancy or been pregnant in last 12 months
History of fits, seizures or blackouts
Parallel participation in other research projects which invole dietary intervention and/or sampling of biological fluids/material which study nurses advice would affect either wellbeing of volunteer or the study data, apart from participation in the FolGene study
Any person related to or living with a member of the study team
Participation in another research project which involves blood sampling within the last 4 months unless total amount blood combined from both studies is less than 470ml
Had donated blood within 16 weeks of starting the study
Prescribed medication for epilepsy/seizures
Diabetics
History of any gastrointestinal disorder requiring medical treatment
Any long term medical condition requiring active treatment which may affect volunteers wellbeing or the study data