Protocol summary

Summary
In this study, the effects of vitamin D and placebo on ultrasonographic and laboratory criteria for fatty liver and some biochemical parameters of blood are compared in overweight and obese children aged 12 to 18 years. The population involves schoolchildren in Birjand among whom a total of 120 will be selected by multi-stage sampling method and will be assigned into control and intervention groups via simple random method (60 in each group). Major inclusion criteria include overweight and obese children based on Centers for Disease Control and Prevention of the United States; children with fatty liver based on ultrasound criteria; and age between 12 and 18 years. Major exclusion criteria include children with underlying conditions including thyroid dysfunction, diabetes and Cushing's syndrome, as well as the chronic consumption of any drug. The study is multi-centered and in the second phase of clinical trials. The intervention group receives 50000 international unit vitamin D as pearl on a weekly basis for 12 weeks; the control group will receive placebo in the same color and dose for the period of time. Before the intervention and at the end of the 12-week intervention, a set of tests were performed for liver enzymes functions (aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase), some biochemical parameters of blood (blood lipids, uric acid, albumin, insulin and fasting blood glucose ), as well as complete blood count with differential, C-reactive protein, vitamin D, and liver ultrasonography.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082017756N23
Registration date: 2017-08-25, 1396/06/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-25, 1396/06/03
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery for Research of Birjand University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vitamin D and placebo application on sonographic, laboratory and some biochemical criteria of fatty liver in overweight and obese children aged between 12 and 18 years
Public title
Effect of vitamin D on sonographic and laboratory and criteria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 12 and 18 years; children with overweight and obesity based on Centers for Disease Control and Prevention of the United States; children with fatty liver based on ultrasound criteria; vitamin D deficiency under laboratory test; willingness to collaborate in the study. Exclusion criteria: Children with background diseases including known thyroid dysfunction (hypothyroidism and hyperparathyroidism), diabetes and Cushing's syndrome; chronic use of any drug such as corticosteroids, and weight reducing and weight gain drugs; history of alcoholism and hepatitis induced by other causes (hereditary diseases, viruses, etc.); and unwillingness to continue cooperation in the study.
Age
From 12 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The study is double-blind; the participants and data collector(s) are uninformed of the study groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice-chancellery for Research, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
Ir.bums.REC.1396.13

Health conditions studied

1

Description of health condition studied
Fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
C-reactive protein
Timepoint
before and after intervention
Method of measurement
Laboratory test in terms of milligram per deciliter

2

Description
Fasting blood sugar
Timepoint
before and after intervention
Method of measurement
Laboratory test in terms of milligram per deciliter

3

Description
Insulin
Timepoint
before and after intervention
Method of measurement
Laboratory test

4

Description
Aspartate Aminotransferase
Timepoint
before and after intervention
Method of measurement
Laboratory test

5

Description
Alanine Aminotransferase
Timepoint
before and after intervention
Method of measurement
Laboratory test

6

Description
Alkaline phosphatase
Timepoint
before and after intervention
Method of measurement
Laboratory test

7

Description
Uric acid
Timepoint
before and after intervention
Method of measurement
Laboratory test

8

Description
hemoglobin
Timepoint
before and after intervention
Method of measurement
Laboratory test

9

Description
Albumin
Timepoint
before and after intervention
Method of measurement
Laboratory test

10

Description
Platelet
Timepoint
before and after intervention
Method of measurement
Laboratory test

11

Description
High-density lipoprotein
Timepoint
before and after intervention
Method of measurement
Laboratory test

12

Description
low density lipoprotein
Timepoint
before and after intervention
Method of measurement
Laboratory test

13

Description
Cholesterol
Timepoint
before and after intervention
Method of measurement
Laboratory test

14

Description
triglyceride
Timepoint
before and after intervention
Method of measurement
Laboratory test

15

Description
Fatty liver
Timepoint
before and after intervention
Method of measurement
Laboratory test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group (Vitamin D capsule): The intervention group receives 50000 international unit vitamin D as pearl on a weekly basis for 12 weeks.
Category
Treatment - Drugs

2

Description
Control Group (Placebo): The control group will receive placebo in the same color and dose for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Mahia Hosseini
Street address
Pediatrics Ward, Vali-e Asr Hospital, Ghaffari St.,
City
Birjand,

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellery of Research and Technology, Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Vice-chancellery of Reasearch and Technology, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery of Research and Technology, Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mahia Hosseini
Position
Assistant of Pediatrics
Other areas of specialty/work
Street address
Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
Hosseini.mahia66@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mahia Hosseini
Position
Assistant of Pediatrics
Other areas of specialty/work
Street address
Faculty of Medicine, Birjand University of Medical Sciecnes, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
Hosseini.mahia66@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Vice-chancellery of Education, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
hadirooz@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...