Estimation of Plasma Folate Apparent Volume of Distribution in Adults (FOLCAN)

February 15, 2013 updated by: Quadram Institute Bioscience
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 6JF
        • Institute of Food Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimation of sampled plasma pool volume of distribution for natural folates
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quadram Institute Bioscience

Collaborators

University of Nottingham

Investigators

  • Principal Investigator: Paul Finglas, Quadram Institute Bioscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 15, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFR4/2008
  • 08/H0310/154

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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