1. Determination of the effect of resveratrol on blood lipid profile
2. Determination of the effect of resveratrol on liver function tests
3. Determination of the effect of resveratrol on lipid peroxidation in plasma samples
Design
Before and after a 1-month course of resveratrol and placebo treatment, 15 ml of intravenous blood is taken from each patient after 12 hours of fasting. Blood samples are sent to the laboratory for the following tests:
1- Blood biochemical tests including lipid profile
2- Liver function tests including ALT and AST
3- Level of fat peroxidation
4- Total plasma antioxidant capacity
Settings and conduct
The clinical trial will be conducted at the Behavioral Sciences Clinic in collaboration with the AIDS Research Center. Among the HIV patients who come to this clinic,
The total number of people living with HIV infection is 200, of which 40 are for the resveratrol group (250 mg per day) and 40 for the placebo group (250 mg starch).
Participants/Inclusion and exclusion criteria
Exclusion criteria:
History of disorders in lipid profile before treatment with antiretroviral drugs, history of cardiovascular and/or cerebral disease, Cushing's syndrome, hypothyroidism, type 1 or type 2 diabetes, renal failure, previous or current treatment with drugs for the treatment of hyperlipidemia and hypertension, estrogens, and current drug and/or alcohol abuse.
Intervention groups
administration of resveratrol with other drugs
Main outcome variables
Cholesterol-Triglyceride - HDL -LDL- ALT- AST- Carbonyl groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038356N2
Registration date:2020-05-23, 1399/03/03
Registration timing:retrospective
Last update:2020-05-23, 1399/03/03
Update count:0
Registration date
2020-05-23, 1399/03/03
Registrant information
Name
Somayyeh Karami-Mohajeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5001
Email address
somayyehkarami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
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
The effect of resveratrol on hyperlipidemia caused by anti-retroviral drug therapy in HIV patients
Public title
The effect of resveratrol on anti-HIV hyperglycemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Sustainable treatment with triple-drug regimen for at least 12 months.
LDL> 130 mg / dL or triglyceride 200-500 mg / dL and HDL> 160 mg / dL,
with no regular diet and exercise for at least 3 months
Exclusion criteria:
Exclusion criteria were: history of pre-antiretroviral lipid disorders,
history of cardiovascular and / or cerebral disease,
Cushing's syndrome,
hypothyroidism,
type 1 or type 2 diabetes,
renal failure,
previous or current treatment with reduced risk factors. Lipid donors,
antihypertensive drugs or estrogens,
current drug and / or alcohol abuse.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drugs were identified by the code provided to the treating physician. The test results were then presented to the statistician and then the groups were analyzed based on the code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Kerman University of Pharmacy, School of Pharmacy, Third Floor, Nursing Home, Dr. Karma Mohajeri
City
kerman
Province
Kerman
Postal code
7618835559
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.KMU.REC.1398.200
Health conditions studied
1
Description of health condition studied
The effect of resveratrol on reducing cholesterol in people with HIV
ICD-10 code
B20-B24
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Triglyceride
Timepoint
1 month
Method of measurement
Each patient received 15 ml fasting venous blood before and after 1 month of treatment with resveratrol and placebo and sent to the laboratory.
2
Description
Cholesterol
Timepoint
1MONTH
Method of measurement
Each patient received 15 ml fasting venous blood before and after 1 month of treatment with resveratrol and placebo and sent to the laboratory.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group
Category
Treatment - Drugs
2
Description
Control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Behavioral Sciences Clinic affiliated to Kerman University of Medical Sciences
Full name of responsible person
Dr. Somayeh Karami Mohajeri
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5239
Email
somayyehkarami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhty
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
76188355559
Phone
+98 34 3132 5239
Email
somayyehkarami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Somayeh Karami Mohajeri
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
pharmacology
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
76188355559
Phone
009831325239
Email
somayyehkarami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
University professor
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
pharmacology
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
76188355559
Phone
009831325239
Email
somayyehkarami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Somayeh Karami Mohajeri
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
pharmacology
Street address
Seven Gardens of Alavi School of Pharmacy
City
kerman
Province
Kerman
Postal code
76188355559
Phone
009831325239
Email
somayyehkarami@gmail.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
Undecided - It is not yet known if there will be 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