Hypomagnesemia Associated With Proton-Pump Inhibitor Use

NCT04426994 | Completed FDA Drug

• 1 other identifier: PPI HypoMg
• Study Type: observational
• Target: 211,672
• Locations: 1 country
• Sites: 1

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

Conditions

Proton Pump Inhibitor Adverse Reaction; Hypomagnesemia; Arrhythmias, Cardiac; Seizures; Hypocalcemia; Hypokalemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Risk factors for Hypomagnesemia

  2013 to 2016

• Hypocalcaemia

  2013 to 2016

• Hypokalemia

  2013 to 2016

Study Arms (2)

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

Control

Patients on long-term proton pump inhibitor without documented hypomagnesemia

Drug: proton pump inhibitor use

Interventions

proton pump inhibitor use DRUG

Patients using long term proton pump inhibitor

Case; Control

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients admitted with hypomagnesemia (cases)
• Patients prescribed with proton pump inhibitors (controls)

You may not qualify if:

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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Seizures; Hypocalcemia; Hypokalemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Officials

• Troy H Puar, MRCP

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: January 31, 2017
• Primary Completion: January 30, 2018
• Study Completion: September 30, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

SG (1)