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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00975351
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : February 18, 2013
University of Nottingham
Information provided by (Responsible Party):
Quadram Institute

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 Not Applicable

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  (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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Estimation of sampled plasma pool volume of distribution for natural folates [ Time Frame: 2 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00975351

United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 6JF
Sponsors and Collaborators
Quadram Institute
University of Nottingham
Principal Investigator: Paul Finglas Quadram Institute

Responsible Party: Quadram Institute Identifier: NCT00975351     History of Changes
Other Study ID Numbers: IFR4/2008
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013

Keywords provided by Quadram Institute:
5-methyltetrahydrofolic acid

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs