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IRCT20160412027346N8 IRCT 2022-08-02 Shahid Beheshti University of Medical Sciences Evaluating the Effect of Zinc supplement on CRP and NLR inflammatory factor in MHD patients Evaluating the Effect of Zinc supplement on CRP and NLR inflammatory factor in MHD patients 2022-08-27 anticipated 40 Complete https://irct.ir/trial/62229 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: The drug and placebo were precisely identical in shape and appearance and prepared in similar packaging. A specific code was assigned to the placebo and a code to the drug. Furthermore, it is presented to the patients according to the randomization table. Only the principal investigator will know the code of the drugs. Medicines are given to patients by ward nurses who do not know the code of medicines, Blinding description: The drug and the placebo are in a package with a standard label and the same amount, and each box is assigned a code that is only available to the researcher, depending on whether it is a drug or a placebo. N/A End stage kidney disease under hemodialysis. Intervention 1: Intervention group: Administration of 50 mg zinc sulfate tablets - once a day - orally - for one month - manufactured by Alhawi company. Intervention 2: Control group: Administration of placebo - once a day - orally. Yes - There is a plan to make this available What will be shared: At the end of the study of all patient data, after making them non-identifiable and performing the statistical analysis mentioned in the work method, necessary reports will be extracted and a part of it related to the main outcome will be shared. When: 6 months after publishing the results To whom: responsible investigator, Physicians, academician investigators Conditions: only with permission of responsible investigator or regulatories Where to obtain: Responsible investigator How to obtain: Through contacting with responsible investigator Comments:
public Shayan Mastoor Tehrani
school of pharmacy, Niayesh crossroad, Vali-asr st.
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8820 0118 Sh.M.Tehrani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr Shadi Ziaie
9th Boostan, Pasdaran Street
Tehran Iran (Islamic Republic of) 2356987452 +98 21 2361 shadiziaie@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People over 18 years old Zinc level less than 70 mcg/ dL Has been on regular hemodialysis for at least 6 month Undergo hemodialysis at least twice a week 18 years no limit Both Patient dissatisfaction Have been hospitalized for the last 3 months Use of zinc supplement in the last two weeks (use of specific multivitamins for dialysis patients is not recommended) Use of selenium supplement in the last two weeks N18.6 End stage renal disease Treatment - Drugs Placebo Intervention group: Administration of 50 mg zinc sulfate tablets - once a day - orally - for one month - manufactured by Alhawi company Control group: Administration of placebo - once a day - orally The effect of zinc supplementation on CRP. Timepoint: The beginning of the study, 30 and 60 days. Method of measurement: Laboratory test. The effect of zinc supplementation on NLR (nutrophil,lymphocyte ratio). Timepoint: The beginning of the study, day 30 and 60. Method of measurement: laboratory test. Shahid Beheshti University of Medical Sciences Approved 2022-03-09 ethics committee of Shahid Beheshti University of Medical Sciences Tehran Province, Tehran, Velenjak, Arabi Ave Tehran Tehran Iran (Islamic Republic of)