Proton Pump Inhibitor Adverse ReactionPPI_HypoMgNCT04426994
Hypomagnesemia Associated With Proton-Pump Inhibitor Use
An observational study of Proton Pump Inhibitor Adverse Reaction and Hypomagnesemia, run by Changi General Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Proton Pump Inhibitor Adverse Reaction, Hypomagnesemia, Arrhythmias, Cardiac
- What is being tested?
- proton pump inhibitor use
- How many people
- 211,672 participants
- Where
- 1 siteSingapore
- Study dates
- 31 Jan 2017to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 100 years
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- Patients admitted with hypomagnesemia (cases)
- Patients prescribed with proton pump inhibitors (controls)
Who cannot join
- Patients prescribed with less than three months duration of proton pump inhibitors (controls)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- proton pump inhibitor use
- Medical subject headings
- Arrhythmias, Cardiac, Seizures, Hypocalcemia, Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton pump inhibitor useDrug
Patients using long term proton pump inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients admitted with hypomagnesemia are evaluated for proton pump inhibitor use and likelihood of hypomagnesemia due to proton pump inhibitor use Receives: Drug: proton pump inhibitor use | |
| Control | Patients on long-term proton pump inhibitor without documented hypomagnesemia Receives: Drug: proton pump inhibitor use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypomagnesemia due to use with proton pump inhibitor
Number of patients with Hypomagnesemia related to use of proton pump inhibitor using Naranjo score
Measured: 2013 to 2016
Secondary outcomes (3)
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
Measured: 2013 to 2016
Hypocalcaemia
Number of patients developing hypocalcemia
Measured: 2013 to 2016
Hypokalemia
Number of patients developing Hypokalemia
Measured: 2013 to 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start31 Jan 2017
- Primary completion30 Jan 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proton Pump Inhibitor Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 211,672 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Troy H Puar, MRCP, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426994
- Sponsor's protocol ID
- PPI HypoMg
- Acronym
- PPI_HypoMg
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised pooled data
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypomagnesemia Associated With Proton-Pump Inhibitor Use
- ClinicalTrials.gov ID
- NCT04426994
- Acronym / sponsor ID
- PPI_HypoMg / PPI HypoMg
- Conditions
- Proton Pump Inhibitor Adverse Reaction, Hypomagnesemia, Arrhythmias, Cardiac, Seizures, Hypocalcemia, Hypokalemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211,672 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Drug: proton pump inhibitor usePatients admitted with hypomagnesemia are evaluated for proton pump inhibitor use and likelihood of hypomagnesemia due to proton pump inhibitor use |
| Control | – | Drug: proton pump inhibitor usePatients on long-term proton pump inhibitor without documented hypomagnesemia |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients admitted with hypomagnesemia (cases)
- Patients prescribed with proton pump inhibitors (controls)
Key exclusion criteria (1 listed)
- Patients prescribed with less than three months duration of proton pump inhibitors (controls)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proton pump inhibitor usePatients using long term proton pump inhibitor | Drug | Case, Control |
Primary outcome
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
3 secondary outcomes
Risk factors for Hypomagnesemia
Time frame: 2013 to 2016
Hypocalcaemia
Time frame: 2013 to 2016
Hypokalemia
Time frame: 2013 to 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: Undecided. Anonymised pooled data
Related trials for Proton Pump Inhibitor Adverse Reaction
Recruiting
Lactobacillus Reuteri Strain Combination in Children Treated With PPI
Gastric Lesion, Proton Pump Inhibitor Adverse Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troy H Puar, MRCP principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proton Pump Inhibitor Adverse Reaction and Hypomagnesemia, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypomagnesemia due to use with proton pump inhibitor (time frame: 2013 to 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.