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IRCT2017101133079N4 IRCT 2017-10-12 Vice chancellor for research, Kashan University of Medical Sciences The effect of Vitamin D Supplementation on Cognitive Functions in Patients Receiving Maintenance Methadone Treatment The effect of Vitamin D Supplementation on Cognitive Functions in Patients Receiving Maintenance Methadone Treatment 2017-04-04 anticipated 70 Complete https://irct.ir/trial/25612 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group, Blinding description: Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff. 2 Addiction. Intervention 1: Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), once every 2 weeks, for 24 weeks orally. Intervention 2: Intervention and control group: Methadone Maintenance Therapy (MMT). 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 Undecided - It is not yet known if there will be a plan to make this available
public Morad Rasouli-Azad
Ravand 5km Road، Medical science collection
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5554 0021 mrasoliazad@yahoo.com Kashan University of Medical Science scientific Morad Rasouli-Azad
Rvand 5Km road, Kashan Medical Science Collection
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5554 0021 mrasoliazad@yahoo.com Kashan University of Medical Science Iran (Islamic Republic of) Patients that receiving methadone maintenance treatment Aged 18 to 60 years 18 years 60 years Both Not living in Kashan Taking vitamin D, multivitamin-mineral, and antioxidant supplements during the last 3 months before the intervention. F19 Mental and behavioural disorders due to psychoactive substance use Treatment - Drugs Treatment - Drugs Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), once every 2 weeks, for 24 weeks orally Intervention and control group: Methadone Maintenance Therapy (MMT) Risky Decision Making. Timepoint: At the baseline and after intervention (24 weeks). Method of measurement: Iowa Gambling Task (IGT). Memory. Timepoint: At the baseline and after intervention (24 weeks). Method of measurement: Wechsler Logic Memory. Verba Fluency. Timepoint: At the baseline and after intervention (24 weeks). Method of measurement: FAS task. Speed Processing. Timepoint: At the baseline and after intervention (24 weeks). Method of measurement: Digit Symbol and Trial Making Test (TMT). Depression. Timepoint: At the baseline and after intervention (24 weeks). Method of measurement: Beck Depression Inventory (BDI). Anxiety. Timepoint: At the baseline and after intervention (24 weeks). Method of measurement: Beck Anxiety Inventory (BAI). Vice chancellor for research, Kashan University of Medical Sciences Approved 2017-02-28 Ethics committee of Kashan University of Medical Sciences Ravand 5km Road، Medical science collection Kashan Isfehan Iran (Islamic Republic of)