The effect of zinc supplementation (Zn) on metabolic profile and expression of IL10, PPARγ, NRF2 genes in methadone maintenance patients
Design
Accidental clinical trial of two concours (both patients and researchers) in parallel.
Settings and conduct
Sample size and study population: 60 patients undergoing treatment with qualified methadone and referred to the Addiction Treatment Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study.
Participants/Inclusion and exclusion criteria
Criteria for entry into the study: Patients undergoing methadone maintenance therapy will enter the study in the age range of 30 to 60 years.Criteria for withdrawal from the study: Lack of willingness to cooperate, zinc consumption in the three months before the intervention, specific disease, positive urine test for methamphetamine and cannabis
Intervention groups
Patients will be divided into zinc (n = 30) or placebo (n = 30) for supplementation. Zinc and placebo supplements are similar in shape and size.
Main outcome variables
Anxiety and depression (primary outcome) and inflammatory factors, oxidative stress, cholesterol, triglycerides, HDL, insulin sensitivity, insulin resistance, fasting blood sugar, serum levels (secondary outcome) will be measured at the beginning and end of the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200708048050N1
Registration date:2020-09-08, 1399/06/18
Registration timing:registered_while_recruiting
Last update:2020-09-08, 1399/06/18
Update count:0
Registration date
2020-09-08, 1399/06/18
Registrant information
Name
Azam Ghsemineghad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5544 3022
Email address
ghaseminejad-a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zinc supplementation (Zn) on metabolic profile and expression of IL10, PPARγ, NRF2 genes in methadone maintenance patients
Public title
Evaluation of the effect of zinc supplementation (Zn) in patients receiving methadone maintenance treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients treated with methadone maintenance in the age range of 30 to 60 years
Exclusion criteria:
Positive urinary test for morphine, methamphetamine and cannabis
Do not have a specific disease
Zinc consumption in the last 3 months
High blood pressure
Consumption of psychiatric and neurological drugs during the study
Digestive problems and side effects of zinc consumption
Consumption of iron supplements
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
How to randomize with a simple method and use random numbers created by computer software (Stat Trek software) will be done. In this method, the computer selects random numbers. By considering numbers for two groups, randomization is done. For example, even numbers will be in the intervention group and odd numbers will be in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo has been used for blinding. Researchers and blind patients will be trained by a staff member until the final analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences Ethics Committee
Street address
Ghotbe Ravandi Boulevard, Kashan
City
kashan
Province
Isfehan
Postal code
8814187159
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.134
Health conditions studied
1
Description of health condition studied
addiction
ICD-10 code
F17.210
ICD-10 code description
مواد مخدر٬ سیگار٬ اعتیاد
Primary outcomes
1
Description
Anxiety
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Beck Depression Inventory
2
Description
Depression
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
1
Description
Total serum cholesterol
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Clinical laboratory kit
2
Description
HDL-C Serum
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Clinical laboratory kit
3
Description
Serum triglyceride
Timepoint
At the beginning of the study and 12 weeks after the interventio
Method of measurement
Clinical laboratory kit
4
Description
Fasting blood sugar
Timepoint
At the beginning of the study and 12 weeks after the interventio
Method of measurement
Enzymatic
5
Description
Insulin
Timepoint
At the beginning of the study and 12 weeks after the interventio
Method of measurement
Eliza
6
Description
Insulin sensitivity
Timepoint
At the beginning of the study and 12 weeks after the interventio
Method of measurement
Formula calculation
7
Description
Insulin resistance
Timepoint
At the beginning of the study and 12 weeks after the interventio
Method of measurement
Formula calculation
8
Description
Total Glutathione
Timepoint
At the beginning of the study and 12 weeks after the interventio
Method of measurement
Spectrophotometry
9
Description
Malone di aldehyde
Timepoint
At the beginning of the study and 12 weeks after the interventio
Method of measurement
Spectrophotometry
10
Description
Expressed levels of PPAR-γ
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
PCR
11
Description
Expressed levels of IL-10
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
PCR
12
Description
Expressed levels of NRF2
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: 30 mg International Zinc Supplement (Jalinous), orally daily for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Jalinous), every day of the week, orally for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Soltan Mirahmad Clinic
Full name of responsible person
Amir Ghaderi
Street address
Shahid Motahari Avenue, Kashan
City
kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 6570
Fax
Email
gaderiam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Azam Ghasemi Nejad
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 7504687
Email
samiraghasemineghad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nejat Khairipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5562 0875
Email
nejatkh.bio@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nejat Khairipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5562 0875
Email
nejatkh.bio@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