PPI_HypoMg: Hypomagnesemia Associated With Proton-Pump Inhibitor Use

• Sponsor: Changi General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04426994
• Collaborator: (none)
• Enrollment: 211,672
• Location: 1
• Actual Duration (Months): 31.9
• Patients Per Site Per Month: 6628.4

Study Details

Study Description

Brief Summary

Use of proton pump inhibitors has been associated with hypomagnesemia. However, various case-control or prospective studies have found conflicting results with regards to proton pump inhibitors use and development of hypomagnesemia. Our aim was to evaluate the likelihood that proton pump inhibitors contributed to severe hypomagnesemia in a retrospective cohort of patients admitted with severe hypomagenesemia. We also aimed to look for risk factors leading to development of hypomagnesemia amongst users of proton pump inhibitors

Condition or Disease	Intervention/Treatment	Phase
Proton Pump Inhibitor Adverse Reaction; Hypomagnesemia; Arrhythmias, Cardiac; Seizures; Hypocalcemia; Hypokalemia	Drug: proton pump inhibitor use

Study Design

• Study Type: Observational
• Actual Enrollment: 211672 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Hypomagnesemia Associated With Proton-Pump Inhibitor Use
• Actual Study Start Date: Jan 31, 2017
• Actual Primary Completion Date: Jan 30, 2018
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Case Patients admitted with hypomagnesemia are evaluated for proton pump inhibitor use and likelihood of hypomagnesemia due to proton pump inhibitor use	Drug: proton pump inhibitor use; Patients using long term proton pump inhibitor
Control Patients on long-term proton pump inhibitor without documented hypomagnesemia	Drug: proton pump inhibitor use; Patients using long term proton pump inhibitor

Outcome Measures

Primary Outcome Measures

1. Hypomagnesemia due to use with proton pump inhibitor [2013 to 2016]

   Number of patients with Hypomagnesemia related to use of proton pump inhibitor using Naranjo score

Secondary Outcome Measures

1. Risk factors for Hypomagnesemia [2013 to 2016]

   Odds ratio of developing Hypomagnesemia with risk factors of age, gender, type of drug, dose of drug, chronic renal failure, use of diuretics

2. Hypocalcaemia [2013 to 2016]

   Number of patients developing hypocalcemia

3. Hypokalemia [2013 to 2016]

   Number of patients developing Hypokalemia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 100 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Patients admitted with hypomagnesemia (cases)

• Patients prescribed with proton pump inhibitors (controls)

Exclusion Criteria:

• Patients prescribed with less than three months duration of proton pump inhibitors (controls)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changi General Hospital	Singapore		Singapore	529889

Sponsors and Collaborators

• Changi General Hospital

Investigators

• Principal Investigator: Troy H Puar, MRCP, Changi General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Changi General Hospital
• ClinicalTrials.gov Identifier: NCT04426994
• Other Study ID Numbers: PPI HypoMg
• First Posted: Jun 11, 2020
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Seizures; Arrhythmias, Cardiac; Hypocalcemia; Hypokalemia; Proton Pump Inhibitors

Study Results

No Results Posted as of Jun 11, 2020