Protocol summary

Study aim
The Effect of Intravenous Vitamin C on Serum Levels of Hepatic Enzymes in patients Poisoned by Opiates Hospitalized.
Design
The clinical trial consisted of vitamin C and randomized placebo group with triple-blind placebo. It is performed on 128 patients with simple randomized.
Settings and conduct
This project is being carried out in the case of poisoned patients with liver damage in Loghman Hakim Hospital in Tehran in a randomized three-blind and sequentially numbered Sealed Opaque Envelops (SNOSE).
Participants/Inclusion and exclusion criteria
Informed written consent to enter the investigation on behalf of the patient or legal guardian. Age between 18 and 65 years old. Any underlying chronic disease such as liver and kidney disease, autoimmunity or cancers. No acute kidney injury. No G6PD Defficiency. Opioid poisoners hospitalized in Loghman Hospital in 2024-2025 whose liver enzyme levels are higher than 5 times normal. Exclusion criteria: In case of oxalate nephropathy or hypernatermia during the treatment procedure, these patients will be excluded from the study.
Intervention groups
128 patients who are referred to Loqman Hospital due to poisoning, if they have Inclusion criteria are included in this study. Patients will be randomly divided into two groups of 64 people as the group receiving intravenous vitamin C or pelcebo.
Main outcome variables
To determine the efficacy of vitamin C doses in the treatment of severe liver damage caused by opium abuse in humans.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240308061217N1
Registration date: 2025-02-28, 1403/12/10
Registration timing: registered_while_recruiting

Last update: 2025-02-28, 1403/12/10
Update count: 0
Registration date
2025-02-28, 1403/12/10
Registrant information
Name
Negin alsadat Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4408 4605
Email address
sadeghi.ne1@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-02-13, 1403/11/25
Expected recruitment end date
2025-07-16, 1404/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of high dose intravenous vitamin C on the serum levels of liver enzymes in patients with hepatic toxicity hospitalized due to opiates.
Public title
vitamin c in hepatotoxicity because of opium abuse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed written consent to enter the investigation on behalf of the patient or legal guardian. Age between 18 and 65 years old. Patients without chronic underlying conditions such as liver and kidney disease, autoimmune disease or cancers Patients do not have acute kidney injury Patients do not have G6PD Deficiency Opioid poisoning hospitalized that the amount of liver enzymes is more than 5 times higher It is normal.
Exclusion criteria:
Lack of written consent from the patient or legal guardian to enter the investigation Any chronic underlying diseases such as liver and kidney disease, autoimmunity, or cancers. No acute kidney injury. 0No G6PDDefficiency Age outside the range of 18-65 years.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups of 64 patients given groups: The groups receiving intravenous vitamin C and the other one placebo . This division will be done by creating a random sequence generation in the form of simple randomization and by preparing and removing the shuffling cards. So that a number of cards will be prepared as the first group and the same number of cards will be prepared for the next groups. Then, by pressing them, a card is taken out and its allocation is recorded, and that card is returned to the sum of the other cards Found. Concealment of random allocation by placing the aforementioned cards inside the envelope Opaque Sealed Sealed Envelops (SNOSE)Performed It will be done. People from the research team who are responsible for the above steps enter the other stages of the investigation, especially the examination of people from the point of view of dependent variables, they will not be.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients were randomly divided into two groups of 64 patients given: The groups receiving intravenous vitamin C and the other placebo. This division will be done by creating a random sequence generation in the form of simple randomization and by preparing and removing the shuffling cards. So that a number of cards will be prepared as the first group and the same number of cards will be prepared for the next groups. Then, by pressing them, a card is taken out and its allocation is recorded, and that card is returned to the sum of the other cards Found. Concealment of random allocation by placing the aforementioned cards inside the envelope Opaque Sealed Sealed Envelops Performed It will be done. People from the research team who are responsible for the above steps enter the other stages of the investigation, especially the examination of people from the point of view of dependent variables, they will not be.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Tehran Medical Azad University of Tehran
Street address
Islamic Azad University of Tehran Medical Sciences,Danesh Street, Zargandeh neighborhood,Tehran,Iran
City
tehran
Province
Tehran
Postal code
1936893813
Approval date
2024-09-01, 1403/06/11
Ethics committee reference number
IR.IAU.TMU.REC.1403.240

Health conditions studied

1

Description of health condition studied
Poisoning
ICD-10 code
T40.2
ICD-10 code description
Other opioids

Primary outcomes

1

Description
Increase serum levels of liver enzymes following opioid abuse.
Timepoint
The serum levels of liver enzymes of the patients are measured daily after enrollment in the study from the first day.
Method of measurement
laboratory kits

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Vitamin C100- 200 mg/kg body weight is administered intravenously along with standard treatment of acute liver failure.
Category
Treatment - Drugs

2

Description
Control group:The second group will receive N/S serum with injected distilled water along with standard treatment (standard treatment is the same in both groups) at the dose of the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
loqman hakim Hospitalloqman hakim Hospital
Full name of responsible person
Dr Peyman Erfantalab Avini
Street address
NO.7, Makhsus St ,Qazvin St ,Tehran ,Iran
City
tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
sadeghinegin19@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
sadeghinegin19@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Negin Alsadat Sadeghi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Emergency Medicine
Street address
No28, Golestan3, Second square of Sadeghiyeh
City
Tehran
Province
Tehran
Postal code
1471693398
Phone
+98 21 4408 4605
Email
sadeghinegin19@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Negin Alsadat Sadeghi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Emergency Medicine
Street address
No28, Golestan3, Second square of Sadeghiye
City
Tehran
Province
Tehran
Postal code
1471693398
Phone
+98 21 4408 4605
Email
sadeghinegin19@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Negin Alsadat Sadeghi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Emergency Medicine
Street address
No 28, Golestan 3, Second square of Sadeghiye
City
Tehran
Province
Tehran
Postal code
1471693398
Phone
+98 21 4408 4605
Email
sadeghinegin19@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
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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