Investigating the effect of melatonin on reducing albuminuria in patients with diabetic nephropathy
Design
This study in phase three has a control group and is conducted in parallel on 38 patients. Random block method will be used for randomization.
Settings and conduct
The work of the clinics of the government hospitals in Ramsar and Tonkabon in is carried out. At the beginning of the study, before the intervention and at the end of the work, ACR, serum creatinine and blood sugar of are evaluated. Patients, evaluators and prescribers are blinded. The method of blinding is in the form of blocking.
Participants/Inclusion and exclusion criteria
Conditions of entry:
All patients with type 2 diabetes whose nephropathy was diagnosed by ACR test (>30 mg/g) during a three-month period
Conditions for not entering:
Patients with heart failure
Pregnant patients
Lactating mothers
Sensitivity to melatonin and its analogues and simultaneous use of interfering drugs such as fluvoxamine,...
Patients with urinary tract infections and uncontrolled blood pressure
Intervention groups
Patients with diabetic nephropathy will be divided into two groups, the intervention group will receive melatonin drug and the control group will receive placebo. Melatonin 10 mg sublingual tablet (1 piece) (manufactured by Norm Life Factory) will be given to the patients one hour before going to sleep and the control group will receive the same amount of placebo tablets for 12 weeks. In addition, patients, evaluators and prescribers will be unaware of the intervention allocation (double-blinded).
At the beginning of the study, before the intervention and at the end of the study, ACR, serum creatinine and blood sugar of the patients are evaluated by the laboratory.
Main outcome variables
Serum level of blood sugar; serum creatinine; hemoglobin; platelet; white blood cell; serum creatinine; GFA; AFR
General information
Reason for update
Acronym
EMS
IRCT registration information
IRCT registration number:IRCT20230212057393N3
Registration date:2024-05-17, 1403/02/28
Registration timing:prospective
Last update:2024-05-17, 1403/02/28
Update count:0
Registration date
2024-05-17, 1403/02/28
Registrant information
Name
Fahimeh Naderi-Behdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5523 1912
Email address
fahime.naderi90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of melatonin supplementation in patients with type 2 diabetes: a randomized: double-blind clinical trial
Public title
Evaluation of the effects of melatonin supplementation in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with type 2 diabetes whose nephropathy was diagnosed through ACR test (>30 mg/gr) during a three-month period
Exclusion criteria:
Patients with heart failure
Pregnant mothers
Lactating mothers
Sensitivity to melatonin and its analogues and simultaneous use of interfering drugs such as fluvoxamine,...
Patients with urinary tract infections and uncontrolled blood pressure
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups, melatonin and placebo, based on the Block Randomization Generator method. In this way, the patients will be divided into 10 blocks of 6 (ABABAB) through random block method.
Blinding (investigator's opinion)
Double blinded
Blinding description
the intervention group will receive melatonin drug and the control group will receive placebo. Melatonin 10 mg sublingual tablet (1 piece) (manufactured by Norm Life Factory) will be given to the patients one hour before going to sleep and the control group will receive the same amount of placebo tablets for 12 weeks. At the same time, the patients, the assessor and the prescriber will be unaware of the allocation of the intervention (double-blinded).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ramsar Autonomous Campus
Street address
The central headquarters course: Revolution Square-Sakhet Sar-Sakhet Sar Street 3-in front of the Department of Education
City
Ramsar
Province
Mazandaran
Postal code
469170001
Approval date
2024-04-07, 1403/01/19
Ethics committee reference number
IR.MAZUMS.RIB.REC.1403.024
Health conditions studied
1
Description of health condition studied
Diabetic nephropathy
ICD-10 code
E16.1Other
ICD-10 code description
Chapter IV Endocrine, nutritional and metabolic diseases(E00-E90)
Primary outcomes
1
Description
Comparison of the nephroprotective effect of melatonin in patients with diabetic nephropathy
Timepoint
At the beginning of the study, before the intervention and at the end of the work after 3 months, ACR, serum creatinine and sugar of the patients are evaluated by a certain laboratory of the effect of oral melatonin drug.
Method of measurement
The effect of melatonin drug on diabetic nephropathy patients is evaluated by using standard laboratory values and laboratory results.
The intervention group will include 30 patients with diabetic nephropathy with ACR greater than 30. 10 mg melatonin supplement made by Norm Life company will be received twice a day for 3 months. In addition to interventional treatment, patients will receive routine treatment including losartan 25-50 mg tablets based on blood pressure.
Category
Treatment - Drugs
2
Description
The control group will include 30 patients with diabetic nephropathy with ACR greater than 30. The placebo supplement will be received twice a day for 3 months in the same way as the original drug manufactured by Norm Life. Patients will receive routine treatment consisting of losartan tablets 25-50 mg based on blood pressure.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital Clinic, Tankabon
Full name of responsible person
Fahime Naderi
Street address
Mazandaran province, Tankabon city, Imam St.
City
Tenkaben
Province
Mazandaran
Postal code
4281989888
Phone
+98 11 5423 7001
Email
rajaeihospital@mazums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Clinic of Imam Sajjad (AS) Ramsar Hospital
Full name of responsible person
Fahime Naderi
Street address
Mazandaran Province, Ramsar City, Shahid Motahari St., Revolution Square, in front of the post office, Imam Sajjad Hospital (AS)
City
Ramsar
Province
Mazandaran
Postal code
4691714143
Phone
+98 11 5522 2031
Email
hospitalimamsajjadramsar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Address of the headquarters: Medan El-Eghlab, 3-Sakhet Sar-Sakhet Sar Street, in front of the Department of Education
City
Ramsar
Province
Mazandaran
Postal code
469170001
Phone
+98 11 5509 1101
Email
ramsar.int.co@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fahime Naderi
Position
Clinical Pharmacy specialist
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Address of the headquarters: Medan El-Eghlab, 3-Sakhet Sar-Sakhet Sar Street, in front of the Department of Education
City
Ramsar
Province
Mazandaran
Postal code
469170001
Phone
+98 11 5509 1101
Email
fahime.naderi90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ramsar Campus University
Full name of responsible person
Fahime Naderi
Position
clinical pharmacy specialist
Latest degree
Specialist
Other areas of specialty/work
clinical pharmacy
Street address
Address of the headquarters: Medan El-Eghlab, 3-Sakhet Sar-Sakhet Sar Street, in front of the Department of Education
City
Ramsar
Province
Mazandaran
Postal code
469170001
Phone
+98 11 5509 1101
Email
fahime.naderi90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fahime Naderi
Position
clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
clinical Pharmacy specialist
Street address
Address of the headquarters: Medan El-Eghlab, 3-Sakhet Sar-Sakhet Sar Street, in front of the Department of Education
City
Ramsar
Province
Mazandaran
Postal code
469170001
Phone
+98 11 5509 1101
Email
fahime.naderi90@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Propoal
When the data will become available and for how long
One year after the completion of the project
To whom data/document is available
colleagues and other researchers
Under which criteria data/document could be used
For further research work
From where data/document is obtainable
Dr. Fahima Naderi
What processes are involved for a request to access data/document
Administrative process to Ramsar Campus University