(1) Objectives: The aim of this study is to investigate the effect of L-carnitine on selected parameters of oxidative stress in patients with Hyperlipidemia. (2) Design: This is a double-blind randomized placebo-controlled study. (3) Setting and conduct: 60 persons who referred to Baqiyatallah clinic(s) will be divided to equal groups, including 30 intervention (supplementation with L - carnitine) and 30 control (placebo) groups. After 14 hours of fasting, the blood samples of two groups will be measured. (4) Participants including major eligibility criteria: Inclusion criteria: Incidence of Hyperlipidemia and age range between 18-65 years; Both groups of males and females; Patients do not use Hypolipidemia drugs in 2 month ago. Exclusion criteria: Hypothyroidism disease; Acute Coronary Disease; Renal disease; Pregnancy; Usage of drugs and alcohol; Inflammatory disease; Chronic Liver Disease (Cirrhosis, Hepatitis, etc.); Anti-seizure drugs; Consumption of antioxidant supplements. (5) Intervention: The L - carnitine tablets will be administered in 2 g/day for the intervention group, and the same dose (2g/day) of placebo for control group in 8 week. During the study, subjects will be advised not to alter their regular diet and level of physical activity. At the end of this study, the parameters of two groups will be measured. (6) main outcome measures (variables): Total antioxidant capacity (TAC ), Malondialdehyde (MDA) and the levels of reduced Glutathione (GSH).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011416214N1
Registration date:2014-03-09, 1392/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-09, 1392/12/18
Registrant information
Name
Hesam Kazemzad
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0153
Email address
abbaszade@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2014-02-04, 1392/11/15
Expected recruitment end date
2014-06-05, 1393/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L - carnitine on selected parameters of oxidative stress in patients with Hyperlipidemia
Public title
Effect of L - carnitine on oxidative stress markers in patients with Hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Incidence of Hyperlipidemia with Cholesterol levels ≥ 200 mg /dL or Triglycerides levels ≥ 200 mg /dL) or LDL ≥ 130; Age range between 18 and 65 years; Both groups of males and females; Patients do not use Hypolipidemia drugs in 2 month ago.
Exclusion criteria: Hypothyroidism disease; Acute Coronary Disease; Renal disease; Pregnancy; Usage of drugs and alcohol; Inflammatory disease; Chronic Liver Disease (Cirrhosis, Hepatitis, etc.); Anti-seizure drugs; Consumption of antioxidant supplements.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Baqiyatallah Medical Sciences University
Street address
Baqiyatallah University of Medical Science, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
340
Health conditions studied
1
Description of health condition studied
Hyperlipidaemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
Total Antioxidant Capacity
Timepoint
Before and after Intervention
Method of measurement
ELISA
2
Description
Serum Malondialdehyde
Timepoint
Before and after Intervention
Method of measurement
Colorimetric
3
Description
GSH
Timepoint
Before and after Intervention
Method of measurement
Colorimetric
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, patients with Hyperlipidemia will receive 2 tablet of L - Carnitine (each tablet 1g) for eight weeks.
Category
Treatment - Drugs
2
Description
In the control group, patients with Hyperlipidemia will receive 2 tablet of placebo (each tablet 1g) for eight weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health School Baqiyatallah University of Medical Sciences
Full name of responsible person
Hesam Kazemzad
Street address
Baqiyatallah University of Medical Science, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Gashtasb Aghasinejad
Street address
Vice chancellor for research of Baqiyatallah University of Medical Sciences, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
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, Baqiyatallah 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
Baqiyatallah University of Medical Science
Full name of responsible person
Hesam Kazemzad
Position
Nutrition and Food Hygiene
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science, South Baqiyatallah University of Medical Science, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8804 0153
Fax
Email
h.kazemzad@yahoo.com
Web page address
http://krause.blogfa.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Mohammd Samadi
Position
MSc
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8804 0153
Fax
+98 21 8804 0153
Email
samadimohammad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Hesam Kazemzad
Position
MSc in Nutrition
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran Tehran
City
Tehran
Postal code
00982188040153
Phone
+98 21 8804 0153
Fax
00982188040153 -00982188600062
Email
h.kazemzad@yahoo.com
Web page address
http://krause.blogfa.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)