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CompletedNCT04426994PPI_HypoMgUpdated Jun 11, 2020

Hypomagnesemia Associated With Proton-Pump Inhibitor Use

An observational study in Proton Pump Inhibitor Adverse Reaction, Hypomagnesemia and Arrhythmias, Cardiac, sponsored by Changi General Hospital. Completed at 1 site in Singapore. Open to participants aged 14 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Changi General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
211,672
Ages
14 Years to 100 Years
Sex
All
01

Study 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

02

Conditions studied

  • Proton Pump Inhibitor Adverse Reaction
  • Hypomagnesemia
  • Arrhythmias, Cardiac
  • Seizures
  • Hypocalcemia
  • Hypokalemia
03

In context

Seizures

881 studies on the registry are indexed under Seizures; 143 are open to participants now.

This study's enrollment of 211,672 is above the median of 150 across 235 observational studies indexed under Seizures.

Browse Seizures studies →

Lead sponsor

Changi General Hospital is the lead sponsor of 98 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 100 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients prescribed with less than three months duration of proton pump inhibitors (controls)
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
211,672 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Drugproton pump inhibitor use

    Patients using long term proton pump inhibitor

06

What researchers measure

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

    Time frame: 2013 to 2016

Secondary outcomes

  1. 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

    Time frame: 2013 to 2016

  2. Hypocalcaemia

    Number of patients developing hypocalcemia

    Time frame: 2013 to 2016

  3. Hypokalemia

    Number of patients developing Hypokalemia

    Time frame: 2013 to 2016

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Study locations

1 site
  • Changi General Hospital
    Singapore, 529889, Singapore
08

References and documents

Individual participant data

Plan to share: Undecided — Anonymised pooled data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04426994
Lead sponsor
Changi General Hospital
Responsible party
Sponsor
First posted
Jun 11, 2020
Start date
Jan 31, 2017
Primary completion
Jan 30, 2018
Completion
Sep 30, 2019
Last update
Jun 11, 2020

Study contacts

Troy H Puar, MRCP
principal investigator · Changi General Hospital

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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