Protocol summary

Study aim
To determine and evaluate the effectiveness of N-acetylcysteine ​​in improving clinical, biochemical, and metabolic indices in children and adolescents with metabolic dysfunction-associated fatty liver disease (MASLD)
Design
A controlled, parallel-group, randomized, phase 3, double-blind clinical trial on 64 children and adolescents with MASLD. Random allocation will be by stratified randomization using a randomized block design (permuted block randomization) with 8 octoploid blocks.
Settings and conduct
This study will be conducted in Children's Medical Center hospitals on 64 children and adolescents with MASLD. The study will be conducted in a double-blind manner with a control group. Given the double-blind nature of the study, the sets of cans containing capsules will be prepared by someone other than the researcher before the study begins, and the placebo will also be similar in appearance to the intervention group. The intervention group will receive daily N-acetylcysteine ​, and the control group will receive placebo for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Overweight and obese pediatrics, having a Z score of body mass index higher than 1 and less than 3 for age and sex, Diagnosis of metabolic dysfunction-associated fatty liver disease by a specialist. Exclusion criteria: chronic disease, intake of medications or supplements that affect appetite, weight or metabolism at least 6 months before the study.
Intervention groups
The intervention group will receive N-acetylcysteine ​​at a dose of 70 mg/kg/day and ursodeoxycholic acid at a dose of 10–15 mg/kg/day for 12 weeks. The control group will receive maltodextrin as a placebo, completely identical to the intervention group, and ursodeoxycholic acid at a dose similar to the intervention group.
Main outcome variables
Liver enzymes, BMI, lipid profile and glycemic factors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220409054467N7
Registration date: 2026-08-08, 1405/05/17
Registration timing: prospective

Last update: 2026-08-08, 1405/05/17
Update count: 0
Registration date
2026-08-08, 1405/05/17
Registrant information
Name
Pejman Rohani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 1417
Email address
rohanipejmanmd@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-13, 1405/05/22
Expected recruitment end date
2027-02-06, 1405/11/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of N-Acetylcysteine in Improving Clinical and Biochemical Parameters of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Children and Adolescents: A double-blind, placebo-controlled clinical trial study
Public title
Efficacy of N-Acetylcysteine in Improving Clinical and Biochemical Parameters of Metabolic Dysfunction-Associated Steatotic Liver Disease in Children and Adolescents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate and sign the informed consent form after full knowledge of the objectives and methods of the study. Girls and boys aged 7 to 18 years. Having a Z score of body mass index higher than 1 and less than 3 for age and sex. Diagnosis of MASLD based on imaging findings and metabolic criteria
Exclusion criteria:
Other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, known autoimmune diseasesو and inherited disorders affecting the liver (iron, copper, etc.). History of alcohol consumption or alcohol consumption more than 10 grams per day in women and more than 20 grams per day in men. Pregnancy or breastfeeding in women Take hepatotoxic drugs such as phenytoin, amoxifen, and lithium celiac disease, diabetes, cardiovascular disease, lung disease, and kidney disease Substance abuse, chronic inflammatory disease, history of cancer, hormone therapy, recent weight loss diet. Consume St. John's wort, omega 3, coenzyme Q10, and carnitine Take medications or supplements that affect appetite, weight, or metabolism for at least 6 months before the study (such as medications that affect carbohydrate, protein, or fat metabolism, and medications that reduce or increase appetite or food intake, including herbal supplements).
Age
From 7 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be used as Stratified Randomization using the Permuted block randomization method with quadruple and eight blocks. According to the sample size of 64 that has been determined, 8 octoploid blocks will be produced using the online site (www.sealedenvelope.com).In the Stratified Randomization method, age and BMI will be used as layers. subjects in each strata will be assigned to treatment or placebo group based on a random list produced by the online site (www.sealedenvelope.com). The random list containing 3-digit codes for each patient that identifies the relevant treatment will be provided to the researcher and will be inserted on the labels of 64 drug bottles. Randomization and blinding of the study are performed to maintain concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. The participants will be divided into 2 groups receiving N-Acetylcysteine and the group receiving placebo. Given the double-blind nature of the study, before the study begins, the sets of cans containing the N-Acetylcysteine supplement will be prepared by someone other than the researcher, and the placebo will also be similar in appearance to the N-Acetylcysteine, so that neither the researcher nor the participant will be aware of the type of treatments received by each group. In addition, during the evaluation of the desired outcomes, the researcher will be unaware of the allocation of participants to each group (intervention and control groups) until after the end of the intervention period.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Digestive Diseases Research Institute- Tehran University of Medical Sc
Street address
Digestive Diseases Research Institute, Shariati Hospital, Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713014
Approval date
2026-07-25, 1405/05/03
Ethics committee reference number
IR.TUMS.DDRI.REC.1405.019

Health conditions studied

1

Description of health condition studied
Metabolic Dysfunction-Associated Steatotic Liver Disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Disease severity index
Timepoint
Beginning and end of the study
Method of measurement
Liver ultrasound

2

Description
Serum Alanine Aminotransferase (ALT) levels
Timepoint
Beginning and end of the study
Method of measurement
Laboratory kit

3

Description
Serum Aspartate Aminotransferase (AST)levels
Timepoint
Beginning and end of the study
Method of measurement
Laboratory kit

Secondary outcomes

1

Description
Body mass index
Timepoint
Beginning and end of the study
Method of measurement
Divide weight in kilograms by height in meters squared

2

Description
Serum glucose levels
Timepoint
Beginning and end of the study
Method of measurement
Laboratory kit

3

Description
Serum triglyceride level
Timepoint
Beginning and end of the study
Method of measurement
Laboratory kit

Intervention groups

1

Description
Intervention group: In this group, individuals take daily N-acetylcysteine ​​at a dose of 70 Milligrams per kilogram of body weight per day in two divided doses, as well as Ursodeoxycholic Acid at a dose of 10–15 Milligrams per kilogram of body weight per day in two divided doses (maximum 1000 Milligrams per day). The drug is supplied by Actover Company.
Category
Treatment - Drugs

2

Description
Control group: In the control group, in addition to ursodeoxycholic acid at the same dose as the intervention group, participants will be given a placebo that is completely identical to the original drug. The placebo is provided by Actover.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
MohammadHassan Sohouli
Street address
Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2089
Email
cmcpr@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Tehran University of Medical Sciences, Keshavarz Blvd, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pejman Rohani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
cmcpr@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pejman Rohani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
cmcpr@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pejman Rohani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
cmcpr@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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