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

Study Overview
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Dietary Supplement: Magnesium Citrate Capsules
* Other: Polyethylene Glycol 3350
* Other: Dulcolax Tablets


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One arm receives Polyethelyne Glycol colonoscopy preparation and the other arm receives magnesium citrate capsules colonoscopy preparation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polyethylene Glycol<br>Polyethylene Glycol 3350: 4 Liters | Other: Polyethylene Glycol 3350<br>* 4 liters of Polyethylene Glycol for colonoscopy preparation<br>|
| Experimental: Magnesium Citrate Capsules<br>36 Magnesium citrate capsules | Dietary Supplement: Magnesium Citrate Capsules<br>* 36 magnesium citrate gelatin capsules<br>Other: Dulcolax Tablets<br>* 4 Dulcolox Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colon Cleanliness | Boston scale rating of colon cleanliness | During colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient compliance and satisfaction | Patient's experience recorded in a questionnaire | On the day of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy preparation, Magnesium Citrate Capsules