NCT00941174|CompletedPhase 1
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Sponsor study identifier
interventional
9
1 country
1
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2009
Actual (reported)Study Completion
March 2009
Actual (reported)The objective of this study is to determine whether the intact human colon with an unaltered microflora distribution absorbs folate and to what extent it is absorbed into the systemic circulation using a dual/oral intravenous route. This will elicit an understanding of colonic folate absorption and metabolism.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
March 2009
Actual (reported)March 2009
Actual (reported)July 14, 2009
Actual (reported)July 17, 2009
Actual (reported)Blood Folate - Study Period 1
Day 1 (Baseline), Day 2 (0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)
Blood Folate - Study Period 2
Day 2 (0h, 0.25h,0.5h,1h,1.5h,2h,2.5h,3h,3.5h,4h)
Urine Folate - Study Period 1
24h, 48h, 72h, 96h
Urine Folate - Study Period 2
24h, 48h, 72h
Dietary Recall Records for folate analysis during urine collection days, Anthropometric.
Study Phase 1 (Day 2,Day 3,Day 4,Day 5) Study Period (Day 2,Day 3,Day 4)
This drug will be used in a clinical trial the objective of which is to determine whether, and to what extent, a physiological concentration of natural folate is absorbed across the large intestine with an intact microflora.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Hospital For Sick Chidlren
Toronto, Ontario, Canada
Lakoff A, Fazili Z, Aufreiter S, Pfeiffer CM, Connolly B, Gregory JF 3rd, Pencharz PB, O'Connor DL. Folate is absorbed across the human colon: evidence by using enteric-coated caplets containing 13C-labeled [6S]-5-formyltetrahydrofolate. Am J Clin Nutr. 2014 Nov;100(5):1278-86. doi: 10.3945/ajcn.114.091785. Epub 2014 Sep 3.
Deborah O'Connor, MD
The Hospital for Sick Children
9 participants (actual enrollment reported by the registry).
First Submitted
July 14, 2009
First Posted
July 17, 2009
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
The Acute Effects of Capsiate During Exercise
Contact the study team to confirm eligibility.
Primary Completion
March 2009
Actual (reported)Study Completion
March 2009
Actual (reported)Last Updated
December 31, 2013
Record last verified: 2013-12
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Source: ClinicalTrials.gov.
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