Hypomagnesemia Associated With Proton-Pump Inhibitor Use (PPI_HypoMg)

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

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac; Seizures; Hypocalcemia; Hypokalemia; Hypomagnesemia; Proton Pump Inhibitor Adverse Reaction
• Intervention / Treatment: Drug: proton pump inhibitor use

• Study Type: Observational
• Enrollment (Actual): 211672

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients managed at a referral centre from 2013 - 2016. Cases were admitted to the referral centre and had documentation hypomagnesemia. Controls were prescribed a course of proton pump inhibitor during the same period

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypomagnesemia due to use with proton pump inhibitor	Number of patients with Hypomagnesemia related to use of proton pump inhibitor using Naranjo score	2013 to 2016

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for Hypomagnesemia	Odds ratio of developing Hypomagnesemia with risk factors of age, gender, type of drug, dose of drug, chronic renal failure, use of diuretics	2013 to 2016
Hypocalcaemia	Number of patients developing hypocalcemia	2013 to 2016
Hypokalemia	Number of patients developing Hypokalemia	2013 to 2016

Collaborators and Investigators

• Sponsor: Changi General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2017
• Primary Completion (ACTUAL): January 30, 2018
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Arrhythmias, Cardiac; Seizures; Hypocalcemia; Hypokalemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Proton Pump Inhibitors
• Other Study ID Numbers: PPI HypoMg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymised pooled data

Drug and device information, study documents

• 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