Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy
Efficacy of Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized, Investigator-blinded Non-inferiority Trial Using Polyethylene Glycol as the Active Control.
1 other identifier
interventional
62
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedStudy Start
First participant enrolled
September 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2020
CompletedMarch 9, 2021
March 1, 2021
2.7 years
August 9, 2017
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colon Cleanliness
Boston scale rating of colon cleanliness
During colonoscopy
Secondary Outcomes (1)
Patient compliance and satisfaction
On the day of colonoscopy
Study Arms (2)
Polyethylene Glycol
ACTIVE COMPARATORPolyethylene Glycol 3350: 4 Liters
Magnesium Citrate Capsules
EXPERIMENTAL36 Magnesium citrate capsules
Interventions
36 magnesium citrate gelatin capsules
4 liters of Polyethylene Glycol for colonoscopy preparation
Eligibility Criteria
You may qualify if:
- Scheduled for colonoscopy at Sinai Hospital or Woodholme GI Associates
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Woodholme Gastroenterology
Baltimore, Maryland, 21208, United States
Sinai Hospital
Baltimore, Maryland, 21215, United States
Related Publications (6)
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.
PMID: 19240699BACKGROUNDKastenberg 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.
PMID: 17198066BACKGROUNDFlemming 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.
PMID: 22192423BACKGROUNDLindberg 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.
PMID: 2407766BACKGROUNDCalderwood 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.
PMID: 24629422BACKGROUNDKastenberg 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.
PMID: 11726845BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ethan Dubin, MD
LifeBridge Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The endoscopist who reports colon cleanliness is blinded to the subject's assignment.
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 11, 2017
Study Start
September 26, 2017
Primary Completion
June 16, 2020
Study Completion
June 16, 2020
Last Updated
March 9, 2021
Record last verified: 2021-03