]>
IRCT20100111003043N15 IRCT 2021-08-14 Tehran University of Medical Sciences The effect of zinc dose on anemia in non-dialysis chronic kidney diseases patients Evaluation of the effect of zinc dose received through supplements for kidney diseases patients in Iran (Nephrovit® or Nephrotonic®) on iron stores and anemia in non-dialysis chronic kidney diseases patients 2021-09-23 anticipated 60 Complete https://irct.ir/trial/56211 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization between two groups of the study is performed by block randomization method with block size of 4. 6 possible arrangements are possible. Excel-derive, random number generation is used for assigning blocks. 15 blocks are selected. 3 Patients with chronic kidney disease stage 3 to 5. Intervention 1: In the control group, patients receive currently available supplements for kidney patients, (nephrovit or nephrotonic containing 25 mg of zinc) daily. Patients' blood samples are taken at the beginning of the study and at the end of 3 months intervention to assess complete blood counts, iron stores, serum zinc, copper and seruloplasmin concentrations. Intervention 2: In the intervention group, new supplement formulation that will be made by Zahravi company will be administered in daily doses. This new formulation contains the same components as nephrotonic with only difference of consisting 7.5 mg zinc instead of 25mg in current formulation. Patients' blood samples are taken at the beginning of the study and at the end of 3 months intervention to assess complete blood counts, iron stores, serum zinc, copper and seruloplasmin concentrations. Yes - There is a plan to make this available What will be shared: The data related to the main outcomes of the study is shared as an SPSS file after deidentifying the individuals. When: The data will be available three months after the results are published. Data would be available for one year. To whom: The data will be made available to researchers working at academic institutions. Conditions: Individuals or institutions that want to use the data must sign a memorandum of understanding with Tehran University of Medical Sciences. Where to obtain: Applicants can contact Dr. Simin Dashti-Khavidaki to receive the data. Phone: 0098-21-66954709 Email: dashtis@tums.ac.ir How to obtain: The applicant's request will be raised in the research session of the Faculty of Pharmacy. After confirmation and signing of the memorandum, the data will be provided to the applicant within about two months. Comments:
public Zahra Nazari Taloki
Enghelab Square, 16 Azar St., FAculty of Pharmacy, Department of Clinical Pharmacy
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4709 zahra.nazari.taloki@gmail.com Tehran University of Medical Sciences scientific Simin Dashti-Khavidaki
Enghelab Square, 16 Azar St., School of Pharmacy, Department of Clinical Pharmacy
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4709 dashtis@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients aged 18-85 years, with stage 3 or more CKD according to the KDIGO guideline, who have been treated with nephrovitis or nephrotonics for more than three months, No significant changes in their diet. 18 years 85 years Both History of chronic infection (AIDS, bacterial, fungal or parasitic infections), severe infection (sepsis) in the last month, cancer, alcohol abuse, use of anemia-inducing drugs (some antibiotics such as linezolid, cotrimoxazole, chloramphenicol and Isoniazid, routine use of nonsteroidal anti-inflammatory drugs, chemotherapy drugs, hydroxyurea, azathioprine, 6-mercaptoporin, sulfasalazine, and methotrexate), treatment with steroids or immunosuppressant, hospitalization, history of blood transfusion within 1 month prior to enrollment. D63.1 Anemia in chronic kidney disease Treatment - Drugs Treatment - Drugs In the control group, patients receive currently available supplements for kidney patients, (nephrovit or nephrotonic containing 25 mg of zinc) daily. Patients' blood samples are taken at the beginning of the study and at the end of 3 months intervention to assess complete blood counts, iron stores, serum zinc, copper and seruloplasmin concentrations. In the intervention group, new supplement formulation that will be made by Zahravi company will be administered in daily doses. This new formulation contains the same components as nephrotonic with only difference of consisting 7.5 mg zinc instead of 25mg in current formulation. Patients' blood samples are taken at the beginning of the study and at the end of 3 months intervention to assess complete blood counts, iron stores, serum zinc, copper and seruloplasmin concentrations. Hemoglobin level. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: blood test. Hematocrit rate. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: blood test. Ferritin level. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: blood test. The amount of serum iron. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: blood test. Plasma level of copper. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: blood test. Plasma level of zinc. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: blood test. Plasma levels of ceruloplasmin. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: blood test. MCV rate. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: blood test. TIBC rate. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: blood test. Mean doses of iron (oral or intravenous). Timepoint: during 1 month before the study, and during the study period. Method of measurement: Prescribed iron. Mean doses of erythropoietin. Timepoint: during 1 month before the study, and during the study period. Method of measurement: Prescribed erythropoietin. Tehran University of Medical Sciences Approved 2021-06-14 Research Ethics committees of the Institute of Pharmaceutical Sciences- Tehran University of Medical 16 Azar Tehran Tehran Iran (Islamic Republic of)