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Completed

NCT Number: NCT04426994

Hypomagnesemia Associated With Proton-Pump Inhibitor Use

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

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Key information

Conditions

Proton Pump Inhibitor Adverse Reaction Arrhythmias, Cardiac Calcium Metabolism Disorders Cardiovascular Diseases Heart Diseases Hypocalcemia Hypokalemia Hypomagnesemia Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Water-Electrolyte Imbalance

Age range

14 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changi General Hospital

Singapore, 529889

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

proton pump inhibitor use

Drug

Patients using long term proton pump inhibitor

Primary outcomes

  1. Hypomagnesemia due to use with proton pump inhibitor

    Time frame: 2013 to 2016

    Number of patients with Hypomagnesemia related to use of proton pump inhibitor using Naranjo score

Secondary outcomes

  1. Risk factors for Hypomagnesemia

    Time frame: 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

  2. Hypocalcaemia

    Time frame: 2013 to 2016

    Number of patients developing hypocalcemia

  3. Hypokalemia

    Time frame: 2013 to 2016

    Number of patients developing Hypokalemia

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Acronym: PPI_HypoMg

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 11, 2020
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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