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IRCT201105186515N1 IRCT 2011-07-02 Vice chancellor for research, Isfahan University of Medical Sciences Effects of Magnesium Carbonate tablet on hyperphosphatemia in patients under hemodialysis Evaluation of effectiveness and safety of Magnesium Carbonate and comparison with calcium carbonate in hyperphosphatemic end stage renal disease patients on chronic hemodialysis. 2010-01-21 anticipated 50 Complete https://irct.ir/trial/6972 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Condition 1: End stage renal disease. Condition 2: hyperphosphatemia. Intervention 1: Control group: 25 ESRD patients on hemodialysis with serum phosphorus > 5.5 mg/dl will use CaCo3 500 mg trice daily with meal if 6.5>P>5.5 one Tablet if 7.5>P>6.5 two tablet will be added and if P> 7.5 or If sever complication happened or if ca x p > 54 the patients will exclude from the study. Intervention 2: Intervention group: 25 ESRD patients on hemodialysis with serum phosphorus > 5.5 mg/dl will use MgCo3 250 mg trice daily with meal if 6.5>P>5.5 one Tablet if 7.5>P>6.5 two tablet and if P> 7.5 three tablets will be added. If sever complication happened (sever diarrhea or cardiac arrhythmia)or if Mg> 4 mg/dl the patient will be excluded and get the needed treatment.
public Dr. Shahrzad Shahidi
Faculty of Medicine, Isfahan University of Medical Sciences, Darvazeh Shiraz
Isfahan Iran (Islamic Republic of) +98 31 1668 5149 research@mui.ac.ir Isfahan University of Medical Sciences scientific Dr. Shahrzad Shahidi
Faculty of Medicine, Isfahan University of Medical Sciences, Darvazeh Shiraz
Isfahan Iran (Islamic Republic of) +98 31 1668 5149 research@mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: age>18 years; serum phosphorus >5.5 mg/dl; at least 3 months on hemodialysis. exclusion criteria: serum magnesium > 4 mg/dl; pregnancy; previous parathyroidectomy; sever hyperparathyroidism(iPTH> 500 pg/ml); Medical disease cause diarrhea; Kidney transplant; Patient Death; Non-compliance of drug usage (at least 80% of prescribed drug must be used); Drug complications making the patient unable to continue the treatment; Lost hemodialysis more than one per month or Irregular hemodialysis 18 years 90 years Both N18.6 E83.39 End Stage Renal Disease classified in other phosphoru metabolism defect. Treatment - Drugs Treatment - Drugs Control group: 25 ESRD patients on hemodialysis with serum phosphorus > 5.5 mg/dl will use CaCo3 500 mg trice daily with meal if 6.5>P>5.5 one Tablet if 7.5>P>6.5 two tablet will be added and if P> 7.5 or If sever complication happened or if ca x p > 54 the patients will exclude from the study. Intervention group: 25 ESRD patients on hemodialysis with serum phosphorus > 5.5 mg/dl will use MgCo3 250 mg trice daily with meal if 6.5>P>5.5 one Tablet if 7.5>P>6.5 two tablet and if P> 7.5 three tablets will be added. If sever complication happened (sever diarrhea or cardiac arrhythmia)or if Mg> 4 mg/dl the patient will be excluded and get the needed treatment. Changes in serum phosphorus level. Timepoint: Before trial and every 2 weeks till at the end of 6the week. Method of measurement: Lab data mg/dl. Changes in Ca X P product. Timepoint: Before trial then every 2 weeks till the end of 6th week. Method of measurement: Lab data mg/dl. Changes in serum calcium. Timepoint: Before trial and every two weeks till the end of 6th week. Method of measurement: Lab data mg/dl. Changes in serum magnesium. Timepoint: Before trial and every two weeks till the end of 6th week. Method of measurement: Lab data, mg/dl. Abdominal pain and diarrhea. Timepoint: Before trial then every 2 weeks till the end of 6th week. Method of measurement: Clinical data(history and examination). Cardiac arhrythmia. Timepoint: Before trial then every 2 weeks till the end of 6th week. Method of measurement: Clinical data(history and examination) and electrocardiography. Serum LDL, HDL, Tg, Chol,. Timepoint: Before trial then at the end of 6th week. Method of measurement: Lab data mg/dl. PTH. Timepoint: Before trial then at the end of 6th week. Method of measurement: Lab data pg/ml. CRP. Timepoint: before trial then every 2 weeks till the end of 6th week. Method of measurement: lab data mg/l. Serum HCo3. Timepoint: Before trial then every 2 weeks till the end of 6th week. Method of measurement: Lab data mmol/l. Blood pressure. Timepoint: Before trial then every 2 weeks till the end of 6th week. Method of measurement: Clinical data(examination) mmHg. Vice chancellor for research, Isfahan University of Medical Sciences Approved 2011-01-04 Ethical commitee of Isfahan University of Medical Sciences Davazeh-Shiraz, Hezar-Jerib St, Isfahan University of Medical Sciences Isfahan Iran (Islamic Republic of)