Comparison of serum level of vitamin D in Patients with Non-alcoholic Fatty Liver Disease (NAFLD) after administration of Oral & Intramuscular Vit D
Design
Two arm parallel group randomised clinical trial
Settings and conduct
Gastrointestinal Clinic of Tabriz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients with non-alcoholic fatty liver (NAFLD) refer to gastrointestinal clinic of Tabriz University of Medical Sciences. Inclusion criteria included: Adolescents over 18 years of age with non-alcoholic fatty liver disease (NAFLD) based on diagnosis of gastroenterologist, evidence of fatty liver based imaging or pathology report, lack of alcohol use, absence Hereditary disease history, lack of osteatogenic drugs, vitamin D deficiency (25-hydroxyvitamin D level less than 20 ng / ml), and patient's informed consent to participate in the study. Exclusion criteria also included other low-level vitamin D diseases such as celiac disease, IBD, cystic fibrosis, short bowel syndrome, a history of thyroid and parathyroid problems, as well as recent consumption of vitamin D, viral hepatitis, and informed consent. The patient is eligible to participate in the study.
Intervention groups
One group of patients will be treated with oral vitamin D (pear vitamin D) at 50,000 units weekly for one month and then 50,000 units monthly for one month. In the second group patients will receive vitamin D of 300,000 units two units within one month.
Main outcome variables
Initial vitamin D levels
Final vitamin D levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190701044062N2
Registration date:2020-01-13, 1398/10/23
Registration timing:prospective
Last update:2020-01-13, 1398/10/23
Update count:0
Registration date
2020-01-13, 1398/10/23
Registrant information
Name
manouchehr khoshbaten
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3010
Email address
mkhoshbaten@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of serum level of vitamin D in Patients with Non-alcoholic Fatty Liver Disease (NAFLD) after administration of Oral & Intramuscular Vit D
Public title
Oral and intramuscular administration of vitamin D in patients with nonalcoholic fatty liver
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Adult Patients Over 18 Years With Non-alcoholic Fatty Liver Disease (NAFLD) Based on Diagnosis of Gastroenterologist Osteatogenic drugs
vitamin D deficiency (25-hydroxyvitamin D level less than 20 ng / ml), and informed patient consent to participate in the study
informed patient consent to participate in the study
Exclusion criteria:
Alcohol consumption
hereditary history
osteogenic drugs
hepatitis
metabolic diseases
Recent consumption of vitamin D
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into oral and muscle groups using randomized block method. Patients will be divided into two equal groups using a random number table. STATA software will be used to generate the random sequence.
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave, imam Reza hospital clinic, tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5154751634
Approval date
2019-11-25, 1398/09/04
Ethics committee reference number
IR.TBZMED.REC.1398.882
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Vitamin D levels in both groups will be measured at baseline. One group of patients will be treated with oral vitamin D (pear vitamin D) at 50,000 units weekly for one month and then 50,000 units monthly for one month. In the second group, patients will receive vitamin D of 300,000 units two months apart. The level of 25-hydroxyvitamin D in both groups will be re-measured 2 months after the start of treatment. The primary outcome of the present study was the level of 25-hydroxyvitamin D levels 3 months after initiation of vitamin D treatment.
Timepoint
Vitamin D levels in both groups will be measured at baseline. It will be re-measured 2 months after the start of treatment.
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : Patients in this group will receive injection muscle vitamin D as 300,000,000 units every month for two month.
Category
Other
2
Description
Control group: In this group, patients will be treated with oral vitamin D (pear vitamin D) 50,000 units weekly for one month and then 50,000 units monthly for one month.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
imam Reza hospital
Full name of responsible person
Manouchehr Khoshbaten
Street address
Golgasht Ave, imam reza hospital clinic, tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmodpour
Street address
Golgasht Ave, imam reza hospital clinic
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2084
Email
a.mahmoodpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Gplgasht Ave, imam reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
golgasht Ave, imam reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
golgasht Ave, imamreza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.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
No - There is not 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