The effects of melatonin supplementation on parathyroid hormone levels in hemodialysis patients : A clinical trial study

To investigate the effect of oral melatonin supplementation on serum levels of PTH, vitamin D, calcium, phosphorus, magnesium, and other electrolytes in patients undergoing hemodialysis with secondary hyperparathyroidism.

A two-group, parallel-group, double-blind (analyzer-blind), randomized, alternating-block, early clinical phase clinical trial on 88 hemodialysis patients. Group allocation was performed using sealed, coded envelopes by an outsider, and the sample size was determined to be 44 in each group.

Hemodialysis patients were selected based on the inclusion criteria and after informed consent, they were randomly divided into two groups. One group received oral melatonin 3 mg daily for 12 weeks and the control group received no pharmacological intervention. Serum levels of PTH, vitamin D, calcium, phosphorus, magnesium and other electrolytes were measured before and after the intervention.

Inclusion criteria: Age over 18 years, hemodialysis patients who have been on dialysis for at least three months, PTH hormone level above 300 Inclusion criteria: Presence of any active or chronic infection

Hemodialysis patients who receive 3 mg of melatonin tablets per day, one hour before bedtime, for 12 weeks, and hemodialysis patients who do not receive any pharmacological intervention (melatonin) and only receive routine dialysis care, are in fact one group receiving melatonin and one group without pharmacological intervention (control).

Serum levels of PTH (parathyroid hormone), serum levels of vitamin D, serum levels of calcium, serum levels of phosphorus, serum levels of magnesium, serum levels of other electrolytes. These variables will be measured before the start of the study and after 12 weeks of intervention in both groups and their changes will be examined.

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.

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.