Effect of Long-Term Use of PPIs on Serum Electrolytes and Vitamins in Patients Reporting to Family Medicine Clinics in Pakistan

The aim of this study was to evaluate the long-term effects of proton pump inhibitors (PPIs) on electrolyte, mineral, and vitamin levels in patients requiring prolonged acid suppression therapy.

A quasi-experimental, parallel-group trial conducted at a single center with a target sample of 60 participants. Participants were randomly assigned in a 1:1 ratio using computerized balloting. Outcome assessment was not blinded, and follow-up was conducted over 12 months.

The trial was conducted at the Department of Family Medicine, Pak Emirates Military Hospital (PEMH). It was a single-center study where participants were recruited from family medicine clinics. The trial was not blinded, and both participants and investigators were aware of the assigned treatments. The trial was carried out from January 2023 to March 2024, with participants followed for 12 months. Data was collected through clinical assessments, blood and stool samples, and interviews at baseline, 3, 6, and 12 months.

Inclusion criteria: Adults (≥18 years) requiring long-term PPI therapy for GERD, chronic gastritis, or Zollinger-Ellison syndrome. Exclusion criteria: Patients with H. pylori-related peptic ulcers, malabsorption conditions, or pre-existing electrolyte/vitamin deficiencies needing treatment.

Participants in the intervention group received oral omeprazole (20–40 mg daily), while the control group received famotidine or sucralfate. Electrolyte, mineral, and vitamin levels were monitored at baseline and at 3, 6, and 12 months. Nutritional supplements were not allowed, and those lost to follow-up were excluded from analysis.

The main outcome measures were changes in electrolyte, mineral, and vitamin levels, as well as treatment side effects and effectiveness.

The randomization process for this trial was conducted using a simple randomization technique, where eligible participants were assigned to either the PPI group or the control group in a 1:1 ratio. Individual participants served as the unit of randomization, and no stratified randomization was applied. The randomization sequence was generated using a random number generator, ensuring an unbiased allocation of participants. Allocation concealment was not explicitly implemented, as the assignments were revealed to investigators at the time of patient enrollment.

All data will be shared with journal in which study will be published.

Data will remain available for scientific community.

Only for academic / scientific community.

Data will be available if asked for statistical analysis for meta-analysis or systemic reviews. Interested individuals can contact any of the authors for deidentified IPD.

Data would be available from institute or from the authors of this research.

Interested party can mail directly to first author using the email provided to obtain the data.