Estimation of Plasma Folate Apparent Volume of Distribution in Adults
FOLCAN
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jun 2009
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 18, 2013
February 1, 2013
6 months
September 10, 2009
February 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimation of sampled plasma pool volume of distribution for natural folates
2 hours
Study Arms (1)
IV dose of 5-methyltetrahydrofolic acid
EXPERIMENTALIV test dose of 13C5-labelled 5-methyltetrahydrofolic acid to all eligible volunteers, followed by regular blood samplings over 2hr period taken via a cannula.
Interventions
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".
Eligibility Criteria
You may qualify if:
- Males and females
- Aged 18-65
- Body mass index above 19.5 and below 40
- Smokers and non-smokers
- Participation in the FolGene study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Quadram Institute Biosciencelead
- University of Nottinghamcollaborator
Study Sites (1)
Institute of Food Research
Norwich, Norfolk, NR4 6JF, United Kingdom
Related Publications (1)
Wright AJ, Finglas PM, Dainty JR, Wolfe CA, Hart DJ, Wright DM, Gregory JF. Differential kinetic behavior and distribution for pteroylglutamic acid and reduced folates: a revised hypothesis of the primary site of PteGlu metabolism in humans. J Nutr. 2005 Mar;135(3):619-23. doi: 10.1093/jn/135.3.619.
PMID: 15735104BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Finglas
Quadram Institute Bioscience
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2009
First Posted
September 11, 2009
Study Start
June 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
February 18, 2013
Record last verified: 2013-02