The purpose of this study is to evaluate the effect of L-carnitine in 60 hyperlipidemic patients referred to Baqiyatallah special clinic. Diagnosis of hyperlipidemia is based on specialist opinion (cholesterol ≥ 200 mg per dL, triglycerides ≥ 200 mg per deciliter; aged between 20 to 65 years). Exclusion criteria: risk hypothyroidism, menopause and pregnancy, smoking, drugs and alcohol, inflammatory diseases, such as diabetes, cancer, based on random assignment to intervention and control groups divided. The intervention group received 2 grams L - Carnitine supplement (Company C, followed by Karen Canada) pill daily for 8 weeks (according to studies) and 2 grams placebo pill daily for placebo group. TG, Total Cholesterol, HDL and LDL was calculated before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011411920N2
Registration date:2014-02-11, 1392/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Sepideh Abbaszadeh
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0153
Email address
abbaszadehs@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2014-01-30, 1392/11/10
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L - carnitine on lipid profile in hyperlipidemic patients referred Hospital Clinic Baqiyatallah
Public title
Effect of L - carnitine in patients with hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
risk of hyperlipidemia in the diagnosis and referral specialist measure cholesterol ≥ 200 mg dL; triglycerides ≥ 200 mg per deciliter;aged between 20 and 65 years; Gender (Female and Male)
Exclusion criteria: hypothyroidism; Pregnancy & menopause;smoking;drugs and alcohol;inflammatory diseases; such as diabetes; cancer; chronic liver disease (Fatty Liver, Cirrhosis of the liver, hepatitis, etc.) and use of Anti-seizure drugs; anti-supplements oxidant.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
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
Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Science, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-11-11, 1392/08/20
Ethics committee reference number
س/340/3/6434
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia
Primary outcomes
1
Description
Lipid Profile ( Tg,Total Chol, LDL-C, HDL-C )
Timepoint
Baseline and the end of the eighth week
Method of measurement
Their past record of blood test with automated analyzers
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group completed 8 weeks of daily 2 g L - Carnitine (Company C, followed by Karen Canada) pill of 1000 mg Oral form
Category
Treatment - Drugs
2
Description
and placebo groups completed 8 weeks 2g daily Oral form use.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
Shahin Vahabi
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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Gashtasb Aghasinejad
Street address
Baqiyatallah University of Medical Science, 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
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 Sciences
Full name of responsible person
shahin vahabi
Position
MSc Student Nutrition
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8804 0153
Fax
Email
shv.2020@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Mohammad Samadi
Position
PhD Student Nutrition
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8804 0153
Fax
Email
SAMADI.MOHAMMAD@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Shahin Vahabi
Position
MSc Student Nutrition
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8804 0153
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)