Protocol summary

Study aim
Determining the effect of vitamins E, C and D individually and synergistically on pain syndrome and withdrawal anxiety caused by drug withdrawal
Design
Clinical trial with a control group, with parallel groups, without blinding, randomized, phase 3 on 125 patients. The rand function of Excel software was used for randomization.
Settings and conduct
After obtaining written consent, 125 drug addicts admitted to Mehr Nervi and Psychiatric Hospital in Khorramabad will be assigned to 5 study groups by simple random method without blinding. These groups include control (without treatment), groups receiving one gram of vitamin C, one thousand units of vitamin D, 400 units of vitamin E and the combination of all three vitamins daily for ten days. Demographic and clinical information of patients will be recorded in the initial evaluation. At the beginning and end of the intervention, the pain and anxiety questionnaire is completed for the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmed diagnosis of substance dependence, Men over 18 years old, The emergence of withdrawal syndrome with the diagnosis of a psychiatrist, Has a score of at least 3 in the VAS test, Exclusion criteria: Taking multivitamin, mineral and antioxidant supplements in the last 3 months before starting the intervention, Liver or kidney failure
Intervention groups
Group one includes samples that do not receive any vitamins. Group 2, 3, 4 and 5 are respectively patients who, in addition to receiving standard treatment, receive 1000 vitamin D capsules, 400 vitamin E capsules, 1 gram effervescent vitamin C tablets and the combination of all three vitamins for ten days.
Main outcome variables
Anxiety and pain from addiction withdrawal

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200721048159N6
Registration date: 2023-07-08, 1402/04/17
Registration timing: prospective

Last update: 2023-07-08, 1402/04/17
Update count: 0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
Forouzan Ahmadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0239
Email address
ahmadpoor.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effects of Vitamins E, C and D Separately and Synergistically on Pain and Anxiety Score Caused by Withdrawal Syndrome in Patients Who are Candidate for Withdrawal: A Randomized Controlled Clinical Trial
Public title
Investigating the Effect of Vitamins E, C and D on Symptoms of Withdrawal Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of opioids and stimulants substances Men over 18 years old The emergence of withdrawal syndrome based on the diagnosis of a psychiatrist a score of at least 3 in the VAS test Performing a TLC test to detect consumption (methadone, morphine, amphetamine and etc..) Consent to participating in the study
Exclusion criteria:
Taking multivitamin, mineral and antioxidant supplements in the last 3 months before starting the intervention Liver or kidney failure
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 125
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization can be done by using the block identifier table and the samples are selected randomly
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Office of Research Ethics Committee, Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
381351698
Approval date
2022-11-08, 1401/08/17
Ethics committee reference number
IR.LUMS.REC.1401.206

Health conditions studied

1

Description of health condition studied
Anxiety and pain caused by drug withdrawal in addicted patients
ICD-10 code
F19.3
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances

Primary outcomes

1

Description
Pain caused by drug withdrawal according to VAS test
Timepoint
Before the start of the intervention and daily for ten days after the start of the intervention
Method of measurement
Test VAS

2

Description
Examining anxiety caused by quitting addiction
Timepoint
Before the start of the intervention and daily for ten days after the start of the intervention
Method of measurement
Beck's anxiety questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: The control group includes samples that do not receive any vitamins
Category
Treatment - Drugs

2

Description
Intervention group1: Intervention group: Patients who, in addition to receiving standard treatment, receive daily dose of vitamin D 1000 unit capsules for ten days.
Category
Treatment - Drugs

3

Description
Intervention group 2: Intervention group: Patients who, in addition to receiving standard treatment, receive daily dose of vitamin E 400 unit capsules for ten days.
Category
Treatment - Drugs

4

Description
Intervention group 3: Patients who, in addition to receiving standard treatment, receive vitamin C effervescent tablets of one gram daily for ten days.
Category
Treatment - Drugs

5

Description
Intervention group 4: Patients who, in addition to receiving standard treatment, receive daily effervescent tablets of vitamin C one gram, vitamin D 1000 units daily and vitamin E 400 units daily for ten days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr Khorramabad Neurological and Psychiatric Hospital
Full name of responsible person
Forouzan Ahmadpour
Street address
3 km of Khorramabad Road, Tehran, Khorramabad, Lorestan
City
khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3324 2430
Email
ahmadpourforoz@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpoor
Street address
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Assistant Professor of Clinical Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
ahmadpourforoz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Assistant Professor of Clinical Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
098 66 33300661
Email
ahmadpourforoz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Assistant Professor of Clinical Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
ahmadpourforoz@yahoo.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
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