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

This study has been completed.
Sponsor:
Collaborator:
University of Nottingham
Information provided by (Responsible Party):
Institute of Food Research
ClinicalTrials.gov Identifier:
NCT00975351
First received: September 10, 2009
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Healthy
 Dietary Supplement: 13C5-labelled 5-methyltetrahydrofolic acid

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Estimation of Plasma Folate Apparent Volume of Distribution in Adults

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Estimation of sampled plasma pool volume of distribution for natural folates [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975351

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

Publications:

Responsible Party: Institute of Food Research
ClinicalTrials.gov Identifier: NCT00975351     History of Changes
Other Study ID Numbers: IFR4/2008, 08/H0310/154
Study First Received: September 10, 2009
Last Updated: February 15, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Institute of Food Research:
folates
5-methyltetrahydrofolic acid
pharmacokinetics
bioavailability
biotransformation

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013