Objective: The aim of this study is to determine the effects of vitamin D supplementation on cognitive functions in maintenance methadone treatment patients. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients of maintenance methadone treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate , current depression, mania and psychosis, and history of head trauma will be excluded in the study. Population and sample size: 70 patients with maintenance methadone treatment of eligible and referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either vitamin D (n=35) or placebo (n=35). Vitamin D and placebos capsules are similar in shape and size. vitamin D serum, Continuum Performance task, Iowa Gambling task, Weschler logic memory, FAS test, Trial Making Task and Digit Symbol were evaluated at baseline and 24 weeks after the intervention. At the beginning and end of the intervention: 24 weeks. Outcomes: cognitive functions (primary outcomes), and depression, anxiety and stress (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101133079N4
Registration date:2017-10-12, 1396/07/20
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-10-12, 1396/07/20
Registrant information
Name
Morad Rasouli-Azad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 989355392455
Email address
rasouliazad-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamin D Supplementation on Cognitive Functions in Patients Receiving Maintenance Methadone Treatment
Public title
The effect of Vitamin D Supplementation on Cognitive Functions in Patients Receiving Maintenance Methadone Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients that receiving maintenance methadone treatment; aged 18 to 60 years. Exclusion criteria: Unwillingness to cooperate, current severe depression, mania or psychosis, head trauma
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ravand 5km Road، Medical science collection
City
Kashan
Postal code
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.KAUMS.REC.1395.166
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use
Primary outcomes
1
Description
Attention
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
continuous performance task (CPT)
2
Description
Risky Decision Making
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Iowa Gambling Task (IGT)
3
Description
Memory
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Wechsler Logic Memory
4
Description
Verba Fluency
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
FAS task
5
Description
Speed Processing
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Digit Symbol and Trial Making Test (TMT)
Secondary outcomes
1
Description
Depression
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Depression, Anxiety, and Stress Scale-21 (DASS-21)
2
Description
Anxiety
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Depression, Anxiety, and Stress Scale-21 (DASS-21)
3
Description
Stress
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Depression, Anxiety, and Stress Scale-21 (DASS-21)
Intervention groups
1
Description
Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), once every 2 weeks, for 24 weeks orally
Category
Treatment - Drugs
2
Description
Intervention and control group: Methadone Maintenance Therapy (MMT)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golabchi Clinic
Full name of responsible person
Morad Rasouli-Azad
Street address
Shahid Rajaee Avenue
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Morad Rasouli-Azad
Position
Assistant Professor
Other areas of specialty/work
Street address
Ravand 5km Road، Medical science collection
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
mrasoliazad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Morad Rasouli-Azad
Position
Assistant professor
Other areas of specialty/work
Street address
Rvand 5Km road, Kashan Medical Science Collection
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
mrasoliazad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Morad Rasouli-Azad
Position
Assistant professor
Other areas of specialty/work
Street address
Rvand 5Km road, Kashan Medical Science Collection
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)