Where is the Initial Site of Biotransformation of Folates in Humans?

NCT02135393 | Completed

• 1 other identifier: UK CRN 5085
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to test the assumption that, in humans, folic acid, a dietary supplement is biotransformed (reduced and methylated) to the natural circulating plasma folate 6S-5Methyltetrahydrofolic acid (5-MTHF) in the intestinal mucosa.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The percentage of folate in un-modified and modified form in the portal vein for each of the different oral folate dosing formulations

  85 minutes

Study Arms (1)

13C5-folic acid or 13C5-6S-5-FormylTHF

EXPERIMENTAL

Physiological 500 nmol (220 µg folic acid equivalent) dose of dietary supplement 13C5-folic acid or 13C5-6S-5-FormylTHF given to subjects with in situ transjugular intrahepatic portosystemic stent at the time of routine venography patency check followed by regular portal venous sampling for 85 minutes at pre determined intervals and then physiological 500 nmol dose of 13C-6S-5-FormylTHF or 13C5-folic acid respectively at the next annual routine venography patency check followed by portal venous sampling for 85 minutes

Dietary Supplement: 13C5-folic acid or 13C5-6S-5-FormylTHF

Interventions

13C5-folic acid or 13C5-6S-5-FormylTHF DIETARY_SUPPLEMENT

Subjects with an insitu transjugular intrahepatic porto systemic stent shunt assigned to receive either a physiological 500 nmol (220 µg folic acid equivalent) dose of 13C5-folic acid or 13C5-6S-5-FormylTHF at the time of routine shunt venography to check patency followed by portal venous sampling at pre defined time points for 85 minutes and then given 13C5-6S-5-FormylTHF ator 13C5-folic acid at their next annual venography patency check with portal venous sampling at pre defined time points for 85 minutes

13C5-folic acid or 13C5-6S-5-FormylTHF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable, synthetic liver function without recent evidence of decompensation (defined as liver function inadequacy or active complications of portal hypertension)
• Abstinent from alcohol
• Free from malignant disease
• Normal gut permeability (as assessed by the lactulose/mannitol test)
• Patent TIPSS on their last surveillance

You may not qualify if:

• Taking Vitamin B supplements
• Taking Folic Acid supplementation
• Unable to provide informed consent

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• Quadram Institute Bioscience: collaborator
• University of Nottingham: collaborator

Study Sites (2)

Freeman Hospital

Newcastle upon Tyne, Tyneside, NE7 7DN, United Kingdom

Location

Institute of Food Research

Norwich, NR47UA, United Kingdom

Location

Related Publications (1)

• Patanwala I, King MJ, Barrett DA, Rose J, Jackson R, Hudson M, Philo M, Dainty JR, Wright AJ, Finglas PM, Jones DE. Folic acid handling by the human gut: implications for food fortification and supplementation. Am J Clin Nutr. 2014 Aug;100(2):593-9. doi: 10.3945/ajcn.113.080507. Epub 2014 Jun 18.

  PMID: 24944062 DERIVED

Study Officials

• David E Jones, PhD FRCP

  Newcastle University

  PRINCIPAL INVESTIGATOR

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: May 8, 2014
• First Posted: May 9, 2014
• Study Start: April 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

GB (2)