The effects of zinc supplementation compared with placebo on ultrasound findings and metabolic profiles in obese children and adolescents with nonalcoholic fatty liver disease
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Protocol summary
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive zinc supplement (n=35) or placebo (n=35).
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive zinc supplement (n=30) or placebo (n=30).
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive zinc supplement (n=3530) or placebo (n=3530).
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. بیماران به دو گروه برای دریافت مکمل یاری روی (35=n) یا پلاسبو (35=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. بیماران به دو گروه برای دریافت مکمل یاری روی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. بیماران به دو گروه برای دریافت مکمل یاری روی (3530=n) یا پلاسبو (3530=n) اختصاص داده خواهند شد.
Among obese children and adolescents with nonalcoholic fatty liver disease referred to Pediatric Clinic of Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 16 weeks after the intervention. At the beginning and the end of the intervention: 16 weeks.
Among obese children and adolescents with nonalcoholic fatty liver disease referred to Pediatric Clinic of Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 16 weeks after the intervention. At the beginning and the end of the intervention: 16 weeks.
Among obese children and adolescents with nonalcoholic fatty liver disease referred to Pediatric Clinic of Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 7060 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 16 weeks after the intervention. At the beginning and the end of the intervention: 16 weeks.
از بین کودکان و نوجوانان چاق مبتلا به بیماری کبد چرب غیر الکلی ارجاع شده به کلینیک اطفال بیمارستان شهید بهشتی وابسته به دانشگاه علوم پزشکی کاشان، 70 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکملها و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 16 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 16هفته
از بین کودکان و نوجوانان چاق مبتلا به بیماری کبد چرب غیر الکلی ارجاع شده به کلینیک اطفال بیمارستان شهید بهشتی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکملها و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 16 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 16هفته
از بین کودکان و نوجوانان چاق مبتلا به بیماری کبد چرب غیر الکلی ارجاع شده به کلینیک اطفال بیمارستان شهید بهشتی وابسته به دانشگاه علوم پزشکی کاشان، 7060 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکملها و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 16 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 16هفته
Intervention group: 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 16 weeks orally. Control group: Placebo (Donyaye Behdasht, Tehran, Iran), daily for 6 weeks orally.
Intervention group: 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 16 weeks orally. Control group: Placebo (Donyaye Behdasht, Tehran, Iran), daily for 16 weeks orally.
Intervention group: 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 16 weeks orally. Control group: Placebo (Donyaye Behdasht, Tehran, Iran), daily for 616 weeks orally.
General information
70
60
7060
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The updating process was done before publishing the paper to correct the registration information.
The updating process was done before publishing the paper to correct the registration information.
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پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 70 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 7060 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
بیماران به طور تصادفی به دو گروه تخصیص داده خواهند شد. یک لیست اعداد تصادفی از 1 تا 70 با استفاده از یک سایت تولید کننده اعداد تصادفی (https://stattrek.com/statistics/random-number-generator.aspx) ایجاد خواهد شد و سپس بیماران با استفاده از اعداد به دو گروه مداخله تخصیص داده خواهند شد. روش تصادفی سازی بلوکی با نسبت 1 به 1 برای رسیدن به دو گروه با حجم نمونه برابر استفاده خواهد شد.
بیماران به طور تصادفی به دو گروه تخصیص داده خواهند شد. یک لیست اعداد تصادفی از 1 تا 60 با استفاده از یک سایت تولید کننده اعداد تصادفی (https://stattrek.com/statistics/random-number-generator.aspx) ایجاد خواهد شد و سپس بیماران با استفاده از اعداد به دو گروه مداخله تخصیص داده خواهند شد. روش تصادفی سازی بلوکی با نسبت 1 به 1 برای رسیدن به دو گروه با حجم نمونه برابر استفاده خواهد شد.
بیماران به طور تصادفی به دو گروه تخصیص داده خواهند شد. یک لیست اعداد تصادفی از 1 تا 7060 با استفاده از یک سایت تولید کننده اعداد تصادفی (https://stattrek.com/statistics/random-number-generator.aspx) ایجاد خواهد شد و سپس بیماران با استفاده از اعداد به دو گروه مداخله تخصیص داده خواهند شد. روش تصادفی سازی بلوکی با نسبت 1 به 1 برای رسیدن به دو گروه با حجم نمونه برابر استفاده خواهد شد.
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of zinc supplementation on on ultrasound findings and metabolic profiles in obese children and adolescents with nonalcoholic fatty liver disease.
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive zinc supplement (n=30) or placebo (n=30).
Settings and conduct
Among obese children and adolescents with nonalcoholic fatty liver disease referred to Pediatric Clinic of Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 16 weeks after the intervention. At the beginning and the end of the intervention: 16 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Obese children and adolescents with nonalcoholic fatty liver disease aged 10 to 18 years old. Exclusion criteria: Taking any antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment, patients with infectious and autoimmune diseases, hypersensitivity to the study medication, and unwillingness to cooperate.
Intervention groups
Intervention group: 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 16 weeks orally. Control group: Placebo (Donyaye Behdasht, Tehran, Iran), daily for 16 weeks orally.
Main outcome variables
Outcomes: hs-CRP (primary outcome) and ultrasound findings, serum liver enzymes, lipid profiles and markers of oxidative damage (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
The updating process was done before publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT20200531047614N1
Registration date:2020-06-19, 1399/03/30
Registration timing:registered_while_recruiting
Last update:2020-08-26, 1399/06/05
Update count:2
Registration date
2020-06-19, 1399/03/30
Registrant information
Name
Mohammad Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
rajabi-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of zinc supplementation compared with placebo on ultrasound findings and metabolic profiles in obese children and adolescents with nonalcoholic fatty liver disease
Public title
Zinc supplementation in treatment of obese children and adolescents with nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obese children and adolescents diagnosed with nonalcoholic fatty liver
Patients aged 10-18 years old.
Exclusion criteria:
Taking any antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment.
Patients with infectious and autoimmune diseases
Hypersensitivity to the study medication.
Unwillingness to cooperate
Age
From 10 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Pediatric clinic of Shahid Beheshti Hospital, affiliated to Kashan University of Medical Science, who is not involved in the trial and not aware of random sequences, will assign the participants to intervention groups. Supplements and placebos are in the same packaging at the Donyaye Behdasht Pharmaceutical company. Only the code is written on the packages. Patients, parents and researchers will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Children, their parents, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.007
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver disease (NAFLD)
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Severity of liver steatosis
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Sonography
2
Description
serum liver enzymes
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
HDL
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Triglycerides
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Glutathione
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 16 weeks of intervention