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NCT03247595 Clinical Trial

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

Colonoscopy Clinical Trial

Official title:
Efficacy of Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized, Investigator-blinded Non-inferiority Trial Using Polyethylene Glycol as the Active Control.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03247595
Other study ID # 1031752
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2017
Est. completion date June 16, 2020

Study information
Verified date March 2021
Source LifeBridge Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date June 16, 2020
Est. primary completion date June 16, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Magnesium Citrate Capsules
36 magnesium citrate gelatin capsules
Other:
• Polyethylene Glycol 3350
4 liters of Polyethylene Glycol for colonoscopy preparation
• Dulcolax Tablets
4 Dulcolox Tablets

Locations
Country Name City State
United States Sinai Hospital Baltimore Maryland
United States Woodholme Gastroenterology Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
LifeBridge Health

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Am J Gastroenterol. 2009 Jun;104(6):1613. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Colon Cleanliness Boston scale rating of colon cleanliness During colonoscopy
Secondary Patient compliance and satisfaction Patient's experience recorded in a questionnaire On the day of colonoscopy
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