NCT02299778

CompletedPhase 1

Bacterially-synthesized Folate Absorption Across the Large I...

The Hospital for Sick Children Source

The Hospital for Sick Children

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

1000026022

Study Type

interventional

Estimated enrollment

10

Locations

1 country

Sites

1

Timeline

Study Start

April 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2015

Actual (reported)

Study Completion

April 2015

Actual (reported)

Brief Summary

The purpose of this study is to determine whether folate produced by bacteria that live in our colon can be absorbed in human colon using a stable isotope method. This study would lead a better understanding of the bioavailability of colonic bacterially-synthesized folate and its quantitative contribution to whole body folate homeostasis.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 10 participants
Study completion date: April 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2014
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 23, 2014
Actual (reported)
First Posted
November 24, 2014
Actual (reported)
Primary Completion
April 2015
Actual (reported)
Study Completion
April 2015
Actual (reported)

Last Updated: October 16, 2015
Status Verified: October 2015
Last Update Submitted: October 14, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

Change in isotopic folate overtime in blood
Baseline (day 1), Days 2-4 ( 0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)
Change in isotopic folate overtime in urine
Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr)

Secondary Outcomes (2)

Folate intake
Day1-4
Fiber intake
Day1-4

Study Arms (1)

1mg of 13C6-p-aminobenzoic acid

EXPERIMENTAL

Dietary Supplement: 13C6-p-aminobenzoic acid

Interventions

13C6-p-aminobenzoic acidDietary supplement

1mg of 13C6-p-aminobenzoic acid

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years;
overall healthy

You may not qualify if:

Sponsors & Collaborators

The Hospital for Sick Children
Otherlead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Study Officials

Deborah L O'Connor, RD, PhD
The Hospital for Sick Children, Toronto, ON, Canada
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Senior Associate Scienitst

Study Record Dates

First Submitted

October 23, 2014

First Posted

November 24, 2014

Study Start

April 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2015

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\<18 years or \>65 years
chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, haematological or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
regular use of medications affecting gastrointestinal pH, motility or folate absorption/metabolism (eg. antiacids, laxatives, phenytoin, sulfasalzine, phenobarbital, primidone, cimetidine, proton pump inhibitors \[such as Nexium\] and antibiotics \[such as Sulfonamides\] or nonsteroidal anti-inflammatory drugs \[NSAIDS, such as aspirin/ibuprofen\])
consumption of \>1 drink/day of alcohol on a regular basis or current smoking (last 6 months)
planning a pregnancy, pregnant, breast feeding or the use of high-dose estrogen oral contraceptives/hormone replacement therapy
known sensitivity to sunscreens containing ultraviolet B filters and/or PABA
difficulty with swallowing large pills or providing venous blood samples

Contact the study team to confirm eligibility.

Actual (reported)

Study Completion

April 2015

Actual (reported)

Last Updated

October 16, 2015

Record last verified: 2015-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02299778
Data provider: ClinicalTrials.gov
Source updated: 2015-10-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:28 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

1mg of 13C6-p-aminobenzoic acid

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

Source record

Locations