Determining the effect of intravenous vitamin C administration on methadone excretion in methadone poisoning patients
Design
Clinical trial with control group, with parallel, randomized groups, phase 2-3 on 54 patients. The random number table was used for randomization.
Settings and conduct
Patients with methadone poisoning who go to Shahid Mostafa Khomeini Hospital will be included in the study. Patients with a history of kidney stones, hemochromatosis, G6PD deficiency, iron overload, and diabetes will be excluded or considered as a control group. Patients who have used a drug or other toxin other than methadone are also excluded. Then 18 patients will be given 12 g of IV Vit C daily (in divided doses of 3 g every 6 hrs), 18 patients will be given 24 g (in divided doses of 6 g every 6 hrs), and 18 patients will not receive any Vit C. Serum levels of methadone and urine pH will be measured at the time of admission and 24 hours after admission (after receiving the fourth dose of vitamin C).
Participants/Inclusion and exclusion criteria
396/5000
Patients with methadone poisoning who visit Shahid Mostafa Khomeini Hospital in Ilam will be included in the study. Patients with a history of kidney stones, hemochromatosis, G6PD deficiency, iron overload, and diabetes will be excluded from the study or treated as a control group to avoid injustice. Patients who have used a drug or other toxin other than methadone are also excluded.
Intervention groups
Eighteen patients will be given 12 grams of intravenous vitamin C daily (in divided doses of 3 g every 6 hours), eighteen patients will be given 24 grams of intravenous vitamin C daily (in divided doses of 6 g every 6 hours), and eighteen patients as a control group will not receive vitamin C.
Main outcome variables
Decreased serum methadone levels; Decreased pH of urine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200621047863N1
Registration date:2020-07-02, 1399/04/12
Registration timing:registered_while_recruiting
Last update:2020-07-02, 1399/04/12
Update count:0
Registration date
2020-07-02, 1399/04/12
Registrant information
Name
maryam sadat hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7134
Email address
m.s.hashemi86@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intravenous vitamin C administration on methadone excretion in methadone toxicity patients
Public title
Evaluation of intravenous vitamin C administration on methadone excretion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with methadone poisoning
Exclusion criteria:
History of kidney stones, hemochromatosis, G6PD deficiency, iron overload and diabetes
Consumption of another substance in addition to methadone
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization of individuals using statistical software
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
Iran National Committee for Ethics in Biomedical Research
Street address
Medical School, Ilam University of Medical Sciences Campus, Pazhoohesh Boulevard, Bangamjab, Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2020-06-21, 1399/04/01
Ethics committee reference number
IR.MEDILAM.REC.1399.106
Health conditions studied
1
Description of health condition studied
methadone poisoning
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum methadone levels
Timepoint
24 hours after the first dose of vitamin C (6 hours after the last dose)
Method of measurement
Laboratory measurement of serum vitamin C level and urine pH
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: 18 patients will receive 12 g of intravenous vitamin C (in divided 3 g doses every 6 hours)
Category
Treatment - Drugs
2
Description
Second Intervention Group: 18 patients will receive 24 g of intravenous vitamin C (in divided 6 g doses every 6 hours)
Category
Treatment - Drugs
3
Description
Control group: 18 patients will receive no vitamin C as the control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini
Full name of responsible person
Maryam Sadat Hashemi
Street address
Shahid Mostafa Khomeini Hospital, Shahed Hill, Shahid Keshvari Square
City
Ilam
Province
Ilam
Postal code
6931934833
Phone
+98 84 3333 8228
Email
m.s.hashemi86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mohammadreza Kaffashian
Street address
Medical School, Ilam University of Medical Sciences Campus, Pazhoohesh Boulevard, Bangamjab
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3222 7134
Email
M_R_KAFFASHIAN@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Maryam Sadat Hashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Medical School, Ilam University of Medical Sciences Campus, Pazhoohesh Boulevard, Bangamjab
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
m.s.hashemi86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Maryam Sadat Hashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Medical School, Ilam University of Medical Sciences Campus, Pazhoohesh Boulevard, Bangamjab
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
m.s.hashemi86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Maryam Sadat Hashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Medical School, Ilam University of Medical Sciences Campus, Pazhoohesh Boulevard, Bangamjab
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
m.s.hashemi86@gmail.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
How to run the study, contextual variables and information about the consequences and results can be published.
When the data will become available and for how long
3 months after publishing the results
To whom data/document is available
All university interested people
Under which criteria data/document could be used
There are no specific restrictions
From where data/document is obtainable
m.s.hashemi86@gmail.com
What processes are involved for a request to access data/document