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Aquamin and Prevention of Colon Cancer
NCT02647671 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02647671 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02647671?
The interventions under investigation include: Placebo (DRUG), Aquamin® (DRUG), Calcium Carbonate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02647671?
This trial is sponsored by James Varani, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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