Effect of melatonin supplementation in treatment of diabetic hemodialysis patients

Clinical trial of the effect of melatonin supplementation compared with the placebo on metabolic status and gene expression related to inflammation, insulin and lipid in diabetic hemodialysis patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N31

Enrollment

Registered

2018-02-14

Start date

2018-02-09

Completion date

Unknown

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis. Chronic kidney disease (CKD)

Interventions

Intervention 1: Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 10 mg, two capsules (5 mg each) one hour before bedtime for 12 weeks orally. Intervention 2: Control group: Placebo (

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: diabetic hemodialysis patients Individuals aged 18 to 80 years old

Exclusion criteria

Exclusion criteria: Exclusion criteria: Patients with infectious, inflammatory and malignant diseases those taking melatonin supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study the night shift workers subjects taking immunosuppressive and antibiotics medications unwillingness to cooperate

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Insulin sensitivity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using formula.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Insulin sensitivity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using formula.

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Secondary

Measure	Time frame
Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of TGF-beta gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of LDLR gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measureme	—

Measure

Time frame

Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of TGF-beta gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of LDLR gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measureme

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026