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IRCT20240505061656N1 IRCT 2025-01-22 Pak Emirates Military Hospital PPIs and micronutrients Effect of Long-Term Use of PPIs on Serum Electrolytes and Vitamins in Patients Reporting to Family Medicine Clinics in Pakistan 2023-01-20 anticipated 44 Complete https://irct.ir/trial/81437 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: 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. 4 Adverse effects of PPIs. Intervention 1: Intervention group 1: Participants in this group received oral omeprazole 20-40 mg daily for long-term acid suppression therapy. Intervention 2: Control group: Participants in this group received either famotidine or sucralfate as an alternative treatment. Yes - There is a plan to make this available What will be shared: All data will be shared with journal in which study will be published. When: Data will remain available for scientific community. To whom: Only for academic / scientific community. Conditions: 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. Where to obtain: Data would be available from institute or from the authors of this research. How to obtain: Interested party can mail directly to first author using the email provided to obtain the data. Comments:
public Mehmood Hussain
Pak Emirates Military Hospital, Rawalpindi Cantt
Rawalpindi Pakistan 46000 +92 346 0551070 mehmoodamcolian@gmail.com Pak Emirates Military Hospital scientific Mehmood Hussain
Pak Emirates Military Hospital, Rawalpindi Cantt
Rawalpindi Cantt Pakistan 46000 +92 346 0551070 mehmoodamcolian@gmail.com Pak Emirates Military Hospital Pakistan Adults ≥18 years of age Had an indication for long-term PPI therapy such as GERD, chronic gastritis or Zollinger Ellison syndrome and willing to participate in this study 18 years no limit Both Peptic ulcer disease secondary to H. pylori Medical condition that cause malabsorption (coeliac disease, chronic pancreatitis, gut resection, inflammatory bowel disease, chronic diarrhea etc) Individuals with pre-existing deficiencies or electrolytes / vitamins requiring intervention E83.42 Hypomagnesemia Treatment - Drugs Treatment - Drugs Intervention group 1: Participants in this group received oral omeprazole 20-40 mg daily for long-term acid suppression therapy. Control group: Participants in this group received either famotidine or sucralfate as an alternative treatment. Magnesium Levels. Timepoint: Baseline, 3-, 6-, 9- and 12-months. Method of measurement: Blood Sample. Calcium Levels. Timepoint: Baseline, 3-, 6-, 9-, 12-months. Method of measurement: Blood test. Phosphate levels. Timepoint: Baseline, 3-, 6-, 9-, 12-months. Method of measurement: Blood test. Serum iron. Timepoint: Baseline, 3-, 6-, 9-, 12-months. Method of measurement: Blood Test. Vitamin B12 levels. Timepoint: Baseline, 3-, 6-, 9-, 12-months. Method of measurement: Blood test. Folate levels. Timepoint: Baseline, 3-, 6-, 9-, 12-months. Method of measurement: Blood test. Vitamin D levels. Timepoint: Baseline, 3-, 6-, 9-, 12-months. Method of measurement: Blood test. Pak Emirate Military Hospital Approved 2023-03-01 Ethical committee, Pak Emirates Military Hospital Pak Emirates Military Hospital, Peshawer Road, Rawalpindi Cantt Rawalpindi Punjab Pakistan