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IRCT20231003059605N1 IRCT 2023-10-31 Pak Emirates Military Hospital Rawalpindi ORAL VERSUS IV IRON THERAPY IN PATIENTS WITH KIDNEY DISEASE COMPARISON OF ORAL VERSUS INTRAVENOUS IRON THERAPY IN IMPROVING HEMOGLOBIN STATUS IN PATIENTS OF CHRONIC KIDNEY DISEASE 2023-01-01 anticipated 210 Complete https://irct.ir/trial/73381 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The RCT included all the assessed participants for eligibility and meeting the inclusion criteria randomized through non-probability consecutive sampling by lottery method through concealed envelopes into the intravenous iron supplementation group (Group I) (n=105) and the oral iron supplementation group (Group O) (n=105). 1-2 Chronic kidney disease. Intervention 1: Intervention group: Intravenous iron supplementation group. Intervention 2: Intervention group: Oral iron intervention group. Yes - There is a plan to make this available What will be shared: All data sets including output sheets made in SPSS 26 will be shared after permission from the author and acceptance of publication of the manuscript When: Data will be available indefinitely to academics after the acceptance of the manuscript for publication To whom: Will be available to academics after permission from the primary author Conditions: The data will be allowed to be used for academic and research purposes Where to obtain: Will be available online on Google drive and link would be sent after acceptance of the manuscript How to obtain: An official request email from the institute or academic email ID for request of data. The application would be processed within 3 days and data would be available within 2 weeks of acceptance by the primary author Comments:
public Hamza Nawaz Chattha
CMH Rawalpindi
Rawalpindi Pakistan 46000 +92 324 5972040 Hamzanawazchattha@gmail.com Pak Emirates Military Hospital Rawalpindi scientific Hamza Nawaz Chattha
CMH Rawalpindi
Rawalpindi Pakistan 46000 +92 324 5972040 Hamzanawazchattha@gmail.com Pak Emirates Military Hospital Rawalpindi Pakistan Inclusion criteria included all male and female patients over the age of 18 years Not on hemodialysis or erythropoietin diagnosed as anemia with a baseline Hb of less than 13 g/dl in males and less than 12 g/dl in females With established chronic kidney disease with a GFR (glomerular filtration rate) of less than 60ml/min for more than 90 days assessed using the CKD-EPI equation and/or hyper albuminuria with urine albumin  30 mg in 24 hours or urine albumin to creatinine ratio (ACR)  30 mg/g. 18 years no limit Both Exclusion criteria included patients on dialysis, erythropoietin or use of erythropoietin stimulating agents (ESAs) in the last 3 months Patients with advanced liver, cardiac or ESKD (end-stage kidney disease) Drug allergies to iron and its supplemental form during therapy or previous known history Unwilling to be included in the study. D63.1 Anemia in chronic kidney disease Treatment - Drugs Treatment - Drugs Intervention group: Intravenous iron supplementation group Intervention group: Oral iron intervention group Serum iron levels. Timepoint: 4 weeks after starting therapy. Method of measurement: Blood levels. Serum Hb. Timepoint: 4 weeks after therapy. Method of measurement: Blood levels. Serum Ferritin levels. Timepoint: 4 weeks after therapy. Method of measurement: Blood levels. Serum transferrin and TIBC levels. Timepoint: 4 weeks after therapy. Method of measurement: Blood levels. Constipation and diarrhea. Timepoint: During 4 weeks of therapy. Method of measurement: Patient history. Allergy to iron supplementation. Timepoint: During 4 weeks of therapy. Method of measurement: Patient assessment weekly during treatment. Pak Emirates Military Hospital Rawalpindi Approved 2022-12-25 ERB Pak Emirates Military Hospital, Rawalpindi Rawalpindi Rawalpindi Punjab Pakistan