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IRCT20251127068128N1 IRCT 2025-11-30 Ahvaz University of Medical Sciences The effect of melatonin consumption on parathyroid hormone levels in patients undergoing hemodialysis. The effects of melatonin supplementation on parathyroid hormone levels in hemodialysis patients : A clinical trial study 2025-11-15 anticipated 88 Recruiting https://irct.ir/trial/87812 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is prepared by a statistician. The intervention used in this study is assigned according to a randomization list by a person outside the study who is unaware of the research objectives and according to the corresponding codes in sealed envelopes. The patient and the doctor have no knowledge of how they are placed in the groups, Blinding description: Patients and physicians do not know who is receiving melatonin, and the data analyst is not aware of the grouping. Group assignment is done by block randomization and coded envelopes by someone outside the study. 3 Name of the disease and condition studied: Chronic kidney disease in hemodialysis patients with secondary hyperparathyroidism. Intervention 1: Intervention group: Intervention group: Hemodialysis patients who received 3 mg of melatonin tablets per day, one hour before bedtime, for 12 weeks. Intervention 2: Control group: Hemodialysis patients who do not receive any pharmacological intervention (melatonin) and only receive routine dialysis care. 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 Still undecided - no release schedule yet
public Shahla Ahmadi Halili
Azadegan St., 24 meters from Imam Khomeini Hospital
Ahvaz Iran (Islamic Republic of) 6193673166 0612222922 ahmadihalili-sh@ajums.ac.ir Ahvaz University of Medical Sciences scientific Shahla Ahmadi Halili
Azadegan., 24 meters., imam khomeini hospital
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 681 6124 ahmadihalili-sh@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Over 18 years old Hemodialysis patients who have been on dialysis for at least three months PTH hormone level above 300 The presence of any active or chronic infection 18 years no limit Both N18 Chronic kidney disease (CKD) Treatment - Other Treatment - Other Intervention group: Intervention group: Hemodialysis patients who received 3 mg of melatonin tablets per day, one hour before bedtime, for 12 weeks. Control group: Hemodialysis patients who do not receive any pharmacological intervention (melatonin) and only receive routine dialysis care. Serum PTH (parathyroid hormone) levels. Timepoint: Beginning of the study (before starting melatonin) End of week 12 (after 3 months of intervention). Method of measurement: Measurement with standard laboratory kits from Imam Hospital. Serum vitamin D levels. Timepoint: Beginning of the study and end of week 12. Method of measurement: Venous blood sample, serum level determination with standard laboratory kit. Serum levels of calcium, phosphorus, and magnesium. Timepoint: Beginning of the study and end of week 12. Method of measurement: Venous blood sample with standard laboratory kits. Serum levels of other electrolytes. Timepoint: Beginning of the study and end of week 12. Method of measurement: Venous blood sample measurement with laboratory kits. Ahvaz University of Medical Sciences Approved 2025-11-15 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Jundishapur University of Medical SciencesŲŒ Koi GolestanŲŒ Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)