Hypomagnesemia Associated With Proton-Pump Inhibitor Use

Completed

• Conditions: Hypomagnesemia; Hypokalemia; Arrhythmias, Cardiac; Seizures; Proton Pump Inhibitor Adverse Reaction; Hypocalcemia
• Interventions: Drug: proton pump inhibitor use

• Registration Number: NCT04426994
• Lead Sponsor: Changi General Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-31
• Primary Completion: 2018-01-30
• Study Completion: 2019-09-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-10
• Last Update Submitted: 2020-06-10
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211672

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	proton pump inhibitor use	Patients admitted with hypomagnesemia are evaluated for proton pump inhibitor use and likelihood of hypomagnesemia due to proton pump inhibitor use
Control	proton pump inhibitor use	Patients on long-term proton pump inhibitor without documented hypomagnesemia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Hypocalcaemia	2013 to 2016	Number of patients developing hypocalcemia
Hypokalemia	2013 to 2016	Number of patients developing Hypokalemia

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore