Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT00975351
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2009-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Estimation of Plasma Folate Apparent Volume of Distribution in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-15', 'studyFirstSubmitDate': '2009-09-10', 'studyFirstSubmitQcDate': '2009-09-10', 'lastUpdatePostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of sampled plasma pool volume of distribution for natural folates', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['folates', '5-methyltetrahydrofolic acid', 'pharmacokinetics', 'bioavailability', 'biotransformation'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '15735104', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.\n\nHealthy 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Aged 18-65\n* Body mass index above 19.5 and below 40\n* Smokers and non-smokers\n* Participation in the FolGene study\n\nExclusion Criteria:\n\n* Pregnancy or been pregnant in last 12 months\n* History of fits, seizures or blackouts\n* 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\n* Any person related to or living with a member of the study team\n* 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\n* Had donated blood within 16 weeks of starting the study\n* Prescribed medication for epilepsy/seizures\n* Diabetics\n* History of any gastrointestinal disorder requiring medical treatment\n* Any long term medical condition requiring active treatment which may affect volunteers wellbeing or the study data'}, 'identificationModule': {'nctId': 'NCT00975351', 'acronym': 'FOLCAN', 'briefTitle': 'Estimation of Plasma Folate Apparent Volume of Distribution in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Quadram Institute Bioscience'}, 'officialTitle': 'Estimation of Plasma Folate Apparent Volume of Distribution in Adults', 'orgStudyIdInfo': {'id': 'IFR4/2008'}, 'secondaryIdInfos': [{'id': '08/H0310/154'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV dose of 5-methyltetrahydrofolic acid', 'description': '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.', 'interventionNames': ['Dietary Supplement: 13C5-labelled 5-methyltetrahydrofolic acid']}], 'interventions': [{'name': '13C5-labelled 5-methyltetrahydrofolic acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['13C5-labelled 5 methyltetrahydrofolic acid, calcium salt', '6S-5-CH3-H4-Pte[13C5] Glu-Ca'], 'description': '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".', 'armGroupLabels': ['IV dose of 5-methyltetrahydrofolic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NR4 6JF', 'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Institute of Food Research', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}], 'overallOfficials': [{'name': 'Paul Finglas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quadram Institute Bioscience'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quadram Institute Bioscience', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nottingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}