Status:
COMPLETED
Estimation of Plasma Folate Apparent Volume of Distribution in Adults
Lead Sponsor:
Quadram Institute Bioscience
Collaborating Sponsors:
University of Nottingham
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
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.
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 car...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00975351
Start Date
June 1 2009
End Date
December 1 2010
Last Update
February 18 2013
Active Locations (1)
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1
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 6JF