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IRCT20190702044076N2 IRCT 2022-11-09 Shahre-kord University of Medical Sciences The effect of niacin on sodium, phosphorus, parathyroid hormone (PTH) and vitamin D levels The effect of niacin on sodium, phosphorus, parathyroid hormone (PTH) and vitamin D levels in hemodialysis patients 2022-12-22 anticipated 60 Complete https://irct.ir/trial/66567 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The type of drug prescribed is randomized by simple randomization among the participants by using the RRApp software. For this purpose, in the order of participation in the research, the participants will receive Niacin (N=30) or placebo (N=30)based on the group they are assigned by RRApp software. Allocation concealment is not carried out. http://clinicalresearch-apps.com/RRApp.html, Blinding description: Patients knowing about the study groups will not be informed about the allocation in treatment groups and this allocation will be done randomly. The statistical analyzer will receive the groups as A and B codes. 3 Dialysis. Intervention 1: Intervention group: This group of patients will take 50 mg niacin tablets daily. Intervention 2: Control group: This group of patients will receive placebo tablets similar to niacin tablets daily. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Faranak Sadat Filsous
No21/Shahid Yarmohammadi Ave/Bagh Ziar Blvd
Esfahan Iran (Islamic Republic of) 8815716191 +98 31 3778 8907 hamidnasri@med.mui.ac.ir Shahre-kord University of Medical Sciences scientific Faranak Sadat Filsous
No21/Shahid Yarmohammadi Ave/Bagh Ziar Blvd
Esfahan Iran (Islamic Republic of) 8815716191 +98 31 3778 8907 hamidnasri@med.mui.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Age over 15 years Phosphorus more than 4.5 At least six months have passed since the start of hemodialysis No change in treatment and hemodialysis protocols in the last two weeks Consent to participate in the study 15 years no limit Both Pregnancy Known liver diseases Active peptic ulcer disease Taking carbamazepine Drug intolerance T81.502 Unspecified complication of foreign body accidentally left in body following kidney dialysis Treatment - Drugs Placebo Intervention group: This group of patients will take 50 mg niacin tablets daily Control group: This group of patients will receive placebo tablets similar to niacin tablets daily Calcium. Timepoint: Before intervention, month 1, 2 and 3. Method of measurement: Blood sampling. Parathyroid hormone. Timepoint: Before intervention, month 1, 2 and 3. Method of measurement: Blood sampling. Phosphorus. Timepoint: Before intervention, month 1, 2 and 3. Method of measurement: Blood sampling. Shahrekrd University of Medical Science Approved 2022-06-22 Ethics committee of Shahrekord of Medical Sciences Num 21/shahid yar mohammadi alley/Bagh ziar Blve Esfahan Isfehan Iran (Islamic Republic of)