The effect of zinc supplementation on blood pressure in dialysis patients

Determining the effect of zinc supplementation on systolic and diastolic blood pressure of dialysis patients

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 130 patients. Block randomization method with Randomization.com online software was used for randomization.

This study will be conducted in the form of a double-blind randomized clinical trial in 1401 at Amirul Mominin Hospital in Arak. In this way, patients with chronic renal failure who are undergoing continuous treatment with hemodialysis will be included in the study after obtaining informed consent. Then the patients will be randomly divided into intervention and control groups. Participating patients, clinical caregivers and researchers will be blinded in this project.

Inclusion criterias: at least 3 months have passed since dialysis, over 18 years old, dialysis at least 2 times a week. Exclusion criterias: pregnancy and breastfeeding, suffering from other chronic diseases, blood transfusion or bleeding during the study

The patients in the intervention group will receive 40 mg oral zinc supplement (Dana Pharmaceutical Company) twice a day for three months in addition to their main drugs since the beginning of the study. Patients in the control group will also receive an oral placebo capsule similar in size, shape and size to the medication in the intervention group twice a day for three months in addition to their main medications.

Systolic blood pressure, diastolic blood pressure

In this method, first, a random sequence is created by one of the mentioned methods, then, based on the sample size of the research, a number of envelopes are prepared with aluminum foil (in order to make the content of the envelopes unclear), and each of the random sequences created is recorded on a card. The cards are placed in the letter envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order.

In this study, the patient, researcher, care personnel and drug prescriber will be blinded. The drug and the placebo, which are already prepared and have the same shape, are distinguished from each other by A and B stickers. Then medicine A and B are distributed by health care workers who have no previous contact with the person distributing the medicine between the patients who have been randomly divided into two groups. The results of experiments and data are collected by the researcher. Only the person analyzing the information knows about drug A and B.