Hypomagnesemia Associated With Proton-Pump Inhibitor Use

Seizures Clinical Trial

— PPI_HypoMg  

Official title:

Hypomagnesemia Associated With Proton-Pump Inhibitor Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426994
• Other study ID #: PPI HypoMg
• Status: Completed
• Start date: January 31, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: June 2020
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211672
• Est. completion date: September 30, 2019
• Est. primary completion date: January 30, 2018
• Gender: All
• Age group: 14 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• proton pump inhibitor use
Patients using long term proton pump inhibitor

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hypocalcaemia	Number of patients developing hypocalcemia	2013 to 2016
Secondary	Hypokalemia	Number of patients developing Hypokalemia	2013 to 2016