Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy

NCT ID: NCT03247595

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-26

Study Completion Date

2020-06-16

Brief Summary

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This study compares a colonoscopy preparation composed of magnesium citrate capsules to a preparation of polyethylene glycol solution. The hypothesis is that the magnesium citrate capsules work as well and are better liked by patients due to the lack of taste.

Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One arm receives Polyethelyne Glycol colonoscopy preparation and the other arm receives magnesium citrate capsules colonoscopy preparation.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators
The endoscopist who reports colon cleanliness is blinded to the subject's assignment.

Study Groups

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Polyethylene Glycol

Polyethylene Glycol 3350: 4 Liters

Group Type ACTIVE_COMPARATOR

Polyethylene Glycol 3350

Intervention Type OTHER

4 liters of Polyethylene Glycol for colonoscopy preparation

Magnesium Citrate Capsules

36 Magnesium citrate capsules

Group Type EXPERIMENTAL

Magnesium Citrate Capsules

Intervention Type DIETARY_SUPPLEMENT

36 magnesium citrate gelatin capsules

Dulcolax Tablets

Intervention Type OTHER

4 Dulcolox Tablets

Interventions

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Magnesium Citrate Capsules

36 magnesium citrate gelatin capsules

Intervention Type DIETARY_SUPPLEMENT

Polyethylene Glycol 3350

4 liters of Polyethylene Glycol for colonoscopy preparation

Intervention Type OTHER

Dulcolax Tablets

4 Dulcolox Tablets

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • Scheduled for colonoscopy at Sinai Hospital or Woodholme GI Associates

Exclusion Criteria

* • Calculated creatinine clearance under 30ml/min

* On PPI and unable to stop for five days before colonoscopy
* On H2 blockers and unable to stop for two days before colonoscopy
* achlorhydria
* Previous colon surgery
* Cardiovascular disease, including uncontrolled congestive heart failure, unstable angina pectoris, or recent (3 months) percutaneous transluminal coronary angioplasty, myocardial infarction, or coronary artery bypass graft surgery
* Colon disease, including chronic constipation (\<2 bowel movements per week for \>1 year), ileus and/or acute obstruction, ileostomy, right or transverse colostomy, subtotal colectomy (≥50% of colon removed) with ileosigmoidostomy, hypomotility syndrome, megacolon, or idiopathic pseudo-obstruction
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LifeBridge Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ethan Dubin, MD

Role: PRINCIPAL_INVESTIGATOR

LifeBridge Health

Locations

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Woodholme Gastroenterology

Baltimore, Maryland, United States

Site Status

Sinai Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009 Mar;104(3):739-50. doi: 10.1038/ajg.2009.104. Epub 2009 Feb 24.

Reference Type BACKGROUND
PMID: 19240699 (View on PubMed)

Kastenberg D, Barish C, Burack H, Dalke DD, Duckor S, Putnam W, Valenzuela G; INKP-100 Study Group. Tolerability and patient acceptance of sodium phosphate tablets compared with 4-L PEG solution in colon cleansing: combined results of 2 identically designed, randomized, controlled, parallel group, multicenter phase 3 trials. J Clin Gastroenterol. 2007 Jan;41(1):54-61. doi: 10.1097/01.mcg.0000212662.66644.76.

Reference Type BACKGROUND
PMID: 17198066 (View on PubMed)

Flemming JA, Vanner SJ, Hookey LC. Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2012 Mar;75(3):537-44. doi: 10.1016/j.gie.2011.09.018. Epub 2011 Dec 21.

Reference Type BACKGROUND
PMID: 22192423 (View on PubMed)

Lindberg JS, Zobitz MM, Poindexter JR, Pak CY. Magnesium bioavailability from magnesium citrate and magnesium oxide. J Am Coll Nutr. 1990 Feb;9(1):48-55. doi: 10.1080/07315724.1990.10720349.

Reference Type BACKGROUND
PMID: 2407766 (View on PubMed)

Calderwood AH, Schroy PC 3rd, Lieberman DA, Logan JR, Zurfluh M, Jacobson BC. Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc. 2014 Aug;80(2):269-76. doi: 10.1016/j.gie.2014.01.031. Epub 2014 Mar 12.

Reference Type BACKGROUND
PMID: 24629422 (View on PubMed)

Kastenberg D, Chasen R, Choudhary C, Riff D, Steinberg S, Weiss E, Wruble L. Efficacy and safety of sodium phosphate tablets compared with PEG solution in colon cleansing: two identically designed, randomized, controlled, parallel group, multicenter phase III trials. Gastrointest Endosc. 2001 Dec;54(6):705-13. doi: 10.1067/mge.2001.119733.

Reference Type BACKGROUND
PMID: 11726845 (View on PubMed)

Other Identifiers

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1031752

Identifier Type: -

Identifier Source: org_study_id

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