Protocol summary

Summary
The present study is a double-blind, placebo-controlled, randomized trial to investigate the effect of coenzyme Q10 on serum concentrations of pentraxin 3 and metabolic parameters in patients with non-alcoholic fatty liver disease (NAFLD). 44 patients with non-alcoholic fatty liver attending the Azadi clinic will be recruited and randomly assigned to receive either the intervention or the placebo. The main inclusion criteria: women aged 20-50 years (premenopausal) and in men 20-65 years and patients newly diagnosed. The main exclusion criteria: any cause of chronic liver disease other than NAFLD; suffering from gastrointestinal disease, diabetes, rheumatoid arthritis, heart failure and renal disease; receiving supplements of vitamins, antioxidants, fiber and omega-3 within 3 weeks before baseline and during the study and using drugs with liver complications. Treatment group will receive one 100 milligram capsule coenzyme Q10 per day and placebo group will receive placebo capsules containing starch for 4 weeks. At baseline and at the endpoint of the study, weight and height will be measured and BMI will be calculated and dietary intake of the participants will be evaluated by 3 dietary record questionnaires. Biochemical variables including plasma level of aspartat aminotransferase, alanine aminotransferase, total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein, fasting blood glucose, insulin resistance, pentraxin 3 will be measured using the appropriate techniques at baseline and endpoint of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305254105N12
Registration date: 2013-06-15, 1392/03/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-15, 1392/03/25
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of coenzyme Q10 on serum concentrations of pentraxin 3 and metabolic parameters in non-alcoholic fatty liver disease
Public title
The Effect of coenzyme Q10 on serum concentrations of pentraxin 3 and metabolic parameters in non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who agree to participate in the study; Women aged 20-50 years (premenopausal) and in men 20-65 years; Patients newly diagnosed. Exclusion criteria: Alcohol intake; Any cause of chronic liver disease other than NAFLD, such as testing positive for hepatitis B, hepatitis C and autoimmune hepatitis – Immune; Suffering from gastrointestinal disease, diabetes and rheumatoid arthritis; Presence of inherited Hemochromatosis (transferrin saturation greater than 45%) and Wilson's disease; Cholestatic liver disease, advanced liver disease, heart failure, thyroid (abnormal TSH) and renal disease; History of cancer and treatment; Receiving supplements of vitamins (A,C,E), antioxidants, fiber and omega-3 within 3 weeks before baseline and during the study; Drugs such as corticosteroids, amiodarone, tamoxifen, cyclins, perhexiline, methotrexate, aspirin and hydralazine; Presence of pregnancy or lactation or menopause; Taking contraceptive drugs; Liver transplantation; Gastric bypass surgery; Performing a complete intravenous feeding; Rapid weight loss; Cut part of the intestine and gastropathy; Follow the diet and weight loss, Cachexia and Taking anticoagulation.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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 and health services
Street address
Golgasht St, Azadi Ave
City
Tabriz
Postal code
Approval date
2013-05-13, 1392/02/23
Ethics committee reference number
9237

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76
ICD-10 code description
Other diseases of liver

Primary outcomes

1

Description
Liver Enzymes(ALT,AST)
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
Autoanalyzer

2

Description
Total Cholesterol
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
Spectrophotometry

3

Description
Triglyceride
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
Spectrophotometry

4

Description
HDL
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
Spectrophotometry

5

Description
LDL
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
Friedewald Formula

6

Description
Insulin
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
ELIZA

7

Description
HOMA-IR
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
Formula

8

Description
Fasting Blood Sugar
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
Spectrophotometry

9

Description
AST/ALT
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
Formula

10

Description
Pentraxin 3
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
ELIZA

Secondary outcomes

1

Description
Food intake
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
dietary record questionnaire

2

Description
Body Mass Index
Timepoint
At baseine and after 4 weeks of intervention
Method of measurement
Scales and meters

Intervention groups

1

Description
One 100 milligram capsule each day for 4 weeks
Category
Treatment - Drugs

2

Description
One capsule containing starch each day for 4 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Azadi clinic in Tabriz
Full name of responsible person
Elnaz Jafarvand
Street address
Azadi clinic, Azadi Ave
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Tabriz University of Medical Science, Golgasht St
City
Tabriz
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
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Beitullah Alipour
Position
Associate Professor
Other areas of specialty/work
Street address
Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
alipourb@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Elnaz Jafarvand
Position
MSc student in Health Sciences in Nutrition
Other areas of specialty/work
Street address
Golgasht Street
City
Tabriz
Postal code
Phone
Fax
Email
elnazjafarvand@yahoo.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
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