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NCT02647671 · ClinicalTrials.gov registry record · Phase 1
Aquamin and Prevention of Colon Cancer
A Phase 1 study of Colonic Cancer, sponsored by James Varani.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT02647671 is a Phase 1 study of Colonic Cancer that has completed, run by James Varani. The registered enrollment target is 36 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02647671, a Phase 1 study of Colonic Cancer, has completed, sponsored by James Varani.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
In the proposed study, investigators will conduct a 90-day dietary intervention study in human subjects. Thirty individuals at risk for adenomatous colon polyp formation will be randomized to receive a calcium and multi-mineral-rich natural product (Aquamin) or a comparable level of calcium alone. There will also be a placebo group. Prior to ingesting the study agents and following the course of treatment, colonic biopsies will be obtained by sigmoidoscopy and quantitatively examined for markers of growth and differentiation. In this study, metabolomic and microbial profiles will also be generated from fecal and colon mucosal samples taken at baseline and study endpoint.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Aquamin®
- DRUG Calcium Carbonate
Study Locations (1)
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2016-04 |
| Est. Completion | 2021-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02647671
The ClinicalTrials.gov registry entry for NCT02647671 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James Varani, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colonic Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02647671 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT02647671 about?
NCT02647671 is a clinical study titled "Aquamin and Prevention of Colon Cancer". In the proposed study, investigators will conduct a 90-day dietary intervention study in human subjects. Thirty individuals at risk for adenomatous colon polyp formation will be randomized to receive a calcium and multi-mineral-rich natural product (Aquamin) or a comparable level of calcium alone. T...
What is the current status of trial NCT02647671?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2016-04. Estimated completion is 2021-03.
What conditions does trial NCT02647671 study?
This clinical trial studies the following conditions: Colonic Cancer.
What interventions are being tested in trial NCT02647671?
The interventions under investigation include: Placebo (DRUG), Aquamin® (DRUG), Calcium Carbonate (DRUG).
Who is sponsoring clinical trial NCT02647671?
This trial is sponsored by James Varani, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02647671 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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