The effects of melatonin supplementation on oxidative stress, inflammatory biomarkers and lipid profile in diabetic patients with chronic kidney disease- a randomized trial

Phase 3

Conditions: Kidney disease in the stage before dialysis (stage 3 and 4).
Chronic kidney disease, unspecified
N18.9

Registration Number: IRCT20170202032367N9

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 48

Inclusion Criteria

Age above 25 and below 65 years
Having CKD in the stage before dialysis (stage 3 to 4) which is diagnosed based on laboratory findings and the opinion of a nephrologist.
Body mass index above 20 and below 30 kg/m2
Willingness to cooperate in this study

Exclusion Criteria

Having CKD due to autoimmune diseases and glomerulonephritis
Blood pressure higher than 100/160 mmHg
Pregnancy or intention to become pregnant within the next 6 months, breastfeeding
Infectious, inflammatory diseases, thyroid gland disorders, thrombocytopenia
Being under enteral and parenteral nutritional support
Taking omega-3 supplements and antioxidant supplements (vitamin E, vitamin C, vitamin B6, selenium, zinc and beta-carotene separately) from 3 months before entering the study
Taking glucocorticoid drugs with a dose of more than 5 mg, antibiotics, fluoxamin, non-steroidal anti-inflammatory drugs, warfarin
smoking
People who have night shift jobs

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum levels of oxidative stress markers (TAC, TOS , MDA). Timepoint: Before the intervention and 10 weeks later. Method of measurement: Pars azmoon kit and spectrophotometry method.;Serum levels of inflammatory markers (hs-CRP, IL-6). Timepoint: Before the intervention and 10 weeks later. Method of measurement: ELISA kit.

Secondary Outcome Measures