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IRCT20200708048050N1 IRCT 2020-09-08 Kashan University of Medical Sciences Evaluation of the effect of zinc supplementation (Zn) in patients receiving methadone maintenance treatment The effect of zinc supplementation (Zn) on metabolic profile and expression of IL10, PPARγ, NRF2 genes in methadone maintenance patients 2020-02-19 anticipated 60 Complete https://irct.ir/trial/49521 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 description: Placebo has been used for blinding. Researchers and blind patients will be trained by a staff member until the final analysis. 3 addiction. Intervention 1: Intervention group: 30 mg International Zinc Supplement (Jalinous), orally daily for 12 weeks. Intervention 2: Control group: Placebo (Jalinous), every day of the week, orally for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet - the release schedule is still unknown
public Azam Ghasemi Nejad
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 7504687 samiraghasemineghad@gmail.com Kashan University of Medical Sciences scientific Nejat Khairipour
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5562 0875 nejatkh.bio@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients treated with methadone maintenance in the age range of 30 to 60 years 30 years 60 years Both 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 F17.210 مواد مخدر٬ سیگار٬ اعتیاد Treatment - Drugs Treatment - Drugs Intervention group: 30 mg International Zinc Supplement (Jalinous), orally daily for 12 weeks. Control group: Placebo (Jalinous), every day of the week, orally for 12 weeks Anxiety. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Beck Depression Inventory. Depression. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Beck Depression Inventory. Total serum cholesterol. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Clinical laboratory kit. HDL-C Serum. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Clinical laboratory kit. Serum triglyceride. Timepoint: At the beginning of the study and 12 weeks after the interventio. Method of measurement: Clinical laboratory kit. Fasting blood sugar. Timepoint: At the beginning of the study and 12 weeks after the interventio. Method of measurement: Enzymatic. Insulin. Timepoint: At the beginning of the study and 12 weeks after the interventio. Method of measurement: Eliza. Insulin sensitivity. Timepoint: At the beginning of the study and 12 weeks after the interventio. Method of measurement: Formula calculation. Insulin resistance. Timepoint: At the beginning of the study and 12 weeks after the interventio. Method of measurement: Formula calculation. Total Glutathione. Timepoint: At the beginning of the study and 12 weeks after the interventio. Method of measurement: Spectrophotometry. Malone di aldehyde. Timepoint: At the beginning of the study and 12 weeks after the interventio. Method of measurement: Spectrophotometry. Expressed levels of PPAR-γ. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: PCR. Expressed levels of IL-10. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: PCR. Expressed levels of NRF2. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: PCR. Kashan University of Medical Sciences Approved 2020-02-17 Kashan University of Medical Sciences Ethics Committee Ghotbe Ravandi Boulevard, Kashan kashan Isfehan Iran (Islamic Republic of)