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

Protocol summary

Study aim
Determining the effects of melatonin supplementation on oxidative stress, inflammation and lipid parameters in diabetic patients with chronic kidney disease
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 48 patients. Sealedenvelope.com is used for randomization.
Settings and conduct
Patients are randomly selected from Shariati hospital clinic patients, Tehran. The supplements are delivered to the patients of both groups and monitored during 10 weeks. At the beginning and end of the study, the main outcome variables are measured.
Participants/Inclusion and exclusion criteria
inclusion criteria: Age 25-65 years; Having CKD before dialysis stages (stage 3 to 4) which is diagnosed based on lab findings and the nephrologist diagnosis; Body mass index 20-30 kg/m2; Willingness to cooperate in study; not inclusion criteria: CKD due to autoimmune diseases and glomerulonephritis; Blood pressure > 160/100 mm Hg; Pregnancy or intention to become pregnant within the next 6 months, breastfeeding; Infectious, inflammatory diseases, thyroid gland disorders, thrombocytopenia; Being under EN and PN support; Taking omega-3 and antioxidant supplements (vitamin E, C, B6, selenium, zinc and beta-carotene separately) from 3 months before the study; Taking glucocorticoids with a dose of more than 5 mg, antibiotics, fluoxamin, NSAIDs, warfarin; smoking; night shift workers
Intervention groups
People in the intervention group will receive 2, 5 mg melatonin supplements daily, and in the control group will receive 2 placebo capsules that are similar to melatonin in terms of appearance, color, smell, taste, and shape, for 10 weeks.
Main outcome variables
Oxidative stress markers; Inflammatory markers; Lipid profile; Renal indicators; Systolic and diastolic blood pressure; FBS and serum insulin; Serum phosphorus levels; Sleep quality score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170202032367N9
Registration date: 2023-08-11, 1402/05/20
Registration timing: prospective

Last update: 2023-08-11, 1402/05/20
Update count: 0
Registration date
2023-08-11, 1402/05/20
Registrant information
Name
Hossien Imani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
h-imani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of melatonin supplementation on oxidative stress, inflammatory biomarkers and lipid profile in diabetic patients with chronic kidney disease- a randomized trial
Public title
The effects of melatonin supplementation on oxidative stress, inflammatory biomarkers and lipid profile in diabetic patients with chronic kidney disease- a randomized trial
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 25 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
48 Patients were randomly assigned to each group (A/B) using block randomization stratified based on age (category1:under 30/category2:above 30) and gender (male/female). Random sequences were generated by creating a blocked randomization list from www.sealedenvelope.com in 12 blocks with a size of 4. Treatment allocation was masked from participants, study personnel, and outcome assessors and was concealed in sequentially numbered, sealed, opaque envelopes. Patients were randomly assigned into two groups in a 1:1 ratio.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the fact that the placebo capsule is similar to melatonin in terms of appearance, color, smell, taste and shape, the people participating in the experiment will not be able to differentiate between the melatonin capsule and the placebo. Blinding of the researcher will be done through the codes included in the packaging of the supplements.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Faculty of Nutrition Sciences and Dietetics, Hojat Dost Alley, Khanaderi, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-07-23, 1402/05/01
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1402.072

Health conditions studied

1

Description of health condition studied
Kidney disease in the stage before dialysis (stage 3 and 4)
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified

Primary outcomes

1

Description
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

2

Description
Serum levels of inflammatory markers (hs-CRP, IL-6)
Timepoint
Before the intervention and 10 weeks later
Method of measurement
ELISA kit

Secondary outcomes

1

Description
Serum levels of lipid parameters (T.G, T.C, LDL, HDL)
Timepoint
Before the intervention and 10 weeks later
Method of measurement
Pars azmoon kit and spectrophotometry method

2

Description
Serum levels of renal indicators (Cr, BUN, uric acid)
Timepoint
Before the intervention and 10 weeks later
Method of measurement
Calorimetric detection kits

3

Description
Systolic and diastolic blood pressure
Timepoint
Before the intervention and 10 weeks later
Method of measurement
Sphygmomanometer and calibrated stethoscope

4

Description
Serum levels of fasting blood sugar and serum insulin
Timepoint
Before the intervention and 10 weeks later
Method of measurement
Diagnostic kits

5

Description
Serum phosphorus level
Timepoint
Before the intervention and 10 weeks later
Method of measurement
Calorimetric detection kit

6

Description
Sleep quality score
Timepoint
Before the intervention and 10 weeks later
Method of measurement
Sleep quality questionnaire (PSQI)

7

Description
Carbohydrate, protein, fat and fiber intake
Timepoint
Before the intervention and 5 and10 weeks later
Method of measurement
24-hour dietary recall (24HR)

Intervention groups

1

Description
Intervention group: Before starting the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake. Then, by using a general questionnaire, information about age, gender, socioeconomic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements, and the duration of the disease will be taken from all people. At the beginning of the study and at the end of the fifth and tenth weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food recall , which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the intervention group will receive 10 mg melatonin supplement (Karen company) in the form of 2, 5 mg supplements per day.
Category
Rehabilitation

2

Description
Control group: Intervention group: Before starting the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake. Then, by using a general questionnaire, information about age, gender, socioeconomic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements, and the duration of the disease will be taken from all people. At the beginning of the study and at the end of the fifth and tenth weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food recall , which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the control group will receive 2 placebo capsules, which are similar to melatonin in terms of appearance, color, smell, taste and shape, for 10 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Sara Sadeghi
Street address
Shariati Hospital, Jalal Al Ahmad Street, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411711335
Phone
+98 21 84901
Email
shariatihosp@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.hossein imani
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossien Imani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+9821889900285
Email
h_imani@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossien Imani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
0098 21 889900285
Email
h_imani@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Sadeghi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Amirabad, North Kargar St
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 937 479 9068
Email
sarah.sadeghi.ss@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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