Protocol summary
-
Study aim
-
The aim of this study is to determine the effects of vitamin D supplementation on cognitive functions in methadone maintenance treatment patients.
-
Design
-
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
-
Settings and conduct
-
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.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Not living in Kashan, Taking vitamin D, multivitamin-mineral, and antioxidant supplements during the last 3 months before the intervention.
-
Intervention groups
-
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.
-
Main outcome variables
-
Cognitive functions (primary outcome), depression and anxiety (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2017101133079N4
Registration date:
2017-10-12, 1396/07/20
Registration timing:
retrospective
Last update:
2019-09-17, 1398/06/26
Update count:
1
-
Registration date
-
2017-10-12, 1396/07/20
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for research, Kashan University of Medical Sciences
-
Expected recruitment start date
-
2017-04-04, 1396/01/15
-
Expected recruitment end date
-
2017-05-05, 1396/02/15
-
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 methadone maintenance treatment
Aged 18 to 60 years
Exclusion criteria:
Not living in Kashan
Taking vitamin D, multivitamin-mineral, and antioxidant supplements during the last 3 months before the intervention.
-
Age
-
From 18 years old to 60 years old
-
Gender
-
Both
-
Phase
-
2
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
70
-
Randomization (investigator's opinion)
-
Randomized
-
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 (investigator's opinion)
-
Double blinded
-
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.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
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
-
Risky Decision Making
-
Timepoint
-
At the baseline and after intervention (24 weeks)
-
Method of measurement
-
Iowa Gambling Task (IGT)
2
-
Description
-
Memory
-
Timepoint
-
At the baseline and after intervention (24 weeks)
-
Method of measurement
-
Wechsler Logic Memory
3
-
Description
-
Verba Fluency
-
Timepoint
-
At the baseline and after intervention (24 weeks)
-
Method of measurement
-
FAS task
4
-
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
-
Beck Depression Inventory (BDI)
2
-
Description
-
Anxiety
-
Timepoint
-
At the baseline and after intervention (24 weeks)
-
Method of measurement
-
Beck Anxiety Inventory (BAI)
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
1
-
Sponsor
-
-
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
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
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