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IRCT20141016019554N13 IRCT 2018-02-17 Zanjan University of Medical Sciences Comparing the effect of sevelamer carbonate and sevelamer hydrochloride on blood level of phosphate, Ca, ph, bicarbonate and gastrointestinal complications in patients undergoing maintenance hemodialysis Comparing the effect of sevelamer carbonate and sevelamer hydrochloride on blood level of phosphate, Ca, ph, bicarbonate and gastrointestinal complications in patients undergoing maintenance hemodialysis 2017-03-21 anticipated 44 Complete https://irct.ir/trial/28916 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: patients were randomized with block randomization method individually.First, patients are matched in terms of age, sex, and level of phosphorus and other variables listed in the criteria for entry and exit, in 4 blocks, each block containing 11 patients. randomization was done by sealed envelopes by a third blinded person who was not one of the researchers, Blinding description: patients and data analyzer were unaware of the type of drugs. drugs were bottled in coded bottles with only the investigator knowing which code refers to which intervention. 3 Calcium, Phosphorus, PH, Bicarbonate and Gastrointestinal Complications in Hemodialysis Patients. Intervention 1: Intervention group 1: 800 mg Sevelamer Carbonate triple time daily with each meal for 1 month. Intervention 2: Intervention group 2: Sevelamer Hydrochloride 800 mg triple daily with each meal for 1 month. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Behrooz Fazeli
Shariati St., Valiasr Hospital
Zanjan Iran (Islamic Republic of) 4515777978 +98 919 674 7560 dr.behroozfazeli@zums.ac.ir Zabol University of Medical Sciences scientific Behrooz Fazeli
Shariati St., Valiasr Hospital
Zanjan Iran (Islamic Republic of) 4515777978 +98 919 674 7560 Dr.behroozfazeli@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients who undergo dialysis three sessions each week for four hours each day. Their blood phosphorus level is higher than 5.5 mg / dL. no limit no limit Both Patients who have not taken limited Phosphorus diet. Patients who lose their ability to participate during the study Patients who are absent from dialysis session Patients who break their access for some reason Patients who have taken the medication inappropriately. Patients with a history of primary hyperparathyroidism or history of parathyroidectomy. Patients with a history of gastrointestinal diseases include peptic ulcer, reflux, and constipation Patients with a history of congestive heart failure (due to electrolyte imbalance) Patients with chronic obstructive pulmonary disease (COPD) (due to acid and basis disorders). N18.4 Chronic kidney disease, stage 4 (severe) Treatment - Drugs Treatment - Drugs Intervention group 1: 800 mg Sevelamer Carbonate triple time daily with each meal for 1 month Intervention group 2: Sevelamer Hydrochloride 800 mg triple daily with each meal for 1 month Blood Calcium. Timepoint: at beginning of intervention and 1 month later. Method of measurement: measurement will be carried out by hospital laboratory. Blood Phosphorus. Timepoint: at beginning of intervention and 1 month later. Method of measurement: measurement will be carried out by hospital laboratory. Blood pH. Timepoint: at beginning of intervention and 1 month later. Method of measurement: measurement will be carried out by hospital laboratory. Blood Bicarbonate levels. Timepoint: at beginning of intervention and 1 month later. Method of measurement: measurement will be carried out by hospital laboratory. Zanjan University of Medical Sciences Approved 2017-07-04 Ethics Committee of Zanjan University of Medical Sciences Khorramshahr Street Zanjan Zanjan Iran (Islamic Republic of)