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NCT01105169 · ClinicalTrials.gov registry record · NA
Precision-Based Magnesium Trial
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
NCT01105169 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 250 participants.
The verdict
NCT01105169, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
Study Summary
Colorectal cancer is the fourth most common incident cancer and the second most common cause of cancer death in the United States, with approximately 150,000 new cases and 57,000 deaths per year. High calcium intake and magnesium may protect against colorectal cancer and adenoma, however, results have been inconsistent. We found that genetic makeup, associated with magnesium absorption and re-absorption, significantly interacted with the calcium and magnesium ratio in relation to the both adenomatous and hyperplastic polyps. Participants who carried at least one 1482Ile allele (G-\>A)of TRPM7 and who consumed diets with a high calcium/magnesium ratio were at a higher risk of adenoma and hyperplastic polyps than were participants who did not carry the polymorphism. We hypothesize that the reduction in the dietary Ca/Mg ratio may change the markers directly related to tumorigenesis. The primary aims of this study are to conduct a randomized placebo-controlled intervention trial to test whether reducing the Ca/mg intake ratio through magnesium supplementation has effects on the related biomarkers. We will also examine whether the effect of modulating Ca/Mg intake ratio may be more pronounced among those who carry the 1482Ile allele compared those who don't carry the 1482Ile allele. Results from our study will help to identify people at a high risk of colorectal adenoma and to develop personalized strategies to prevent occurrence of colorectal adenoma, and thus, colorectal cancer through dietary change or nutritional fortification.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Magnesium glycinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2011-03-11 |
| Est. Completion | 2025-07-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01105169
The ClinicalTrials.gov registry entry for NCT01105169 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01105169 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01105169 about?
NCT01105169 is a clinical study titled "Precision-Based Magnesium Trial". Colorectal cancer is the fourth most common incident cancer and the second most common cause of cancer death in the United States, with approximately 150,000 new cases and 57,000 deaths per year. High calcium intake and magnesium may protect against colorectal cancer and adenoma, however, results ha...
What is the current status of trial NCT01105169?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2011-03-11. Estimated completion is 2025-07-08.
What interventions are being tested in trial NCT01105169?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Magnesium glycinate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01105169?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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