1. Home
  2. Approved trials
  3. » فارسی

The effect of L carnitine on clinical symptoms, lipid profile and oxidative stress in obese women with knee osteo arthiritis under weight loss diet

Protocol summary

Summary
In this study, the effects of L carnitine on clinical symptoms, lipid profile and oxidative stress in women with osteoarthritis, was investigated. The design of study is a double-blind randomized clinical trial. In this clinical trial, 76 women with osteoarthritis will be randomly assigned to 2 groups by using the table of random numbers: 1) Consuming one tablet 1000 mg L carnitine AND weight loss diet 2) Consuming one tablet placebo with weight loss diet. Inclusion criteria will include women between 45- 70 years, body mass index(BMI) more than 25 and exclusion criteria will include disease such as heart disease, hypothyroidism, rheumatoid arthritis , hepatic disease, kidney disease. Participants will be followed up for 12 weeks. Total cholesterol, triglyceride, high density lipoprotein cholesterol, C reactive protein(CRP), Malondialdehyde (MDA), weight, height, fat mass, fat free mass, waist, Hip circumference, Western Ontario and McMaster Universities Arthritis Index(WOMAC)(for pain) will be measured at the baseline and at the end of the trial. Low density lipoprotein level will be calculated by the Friedewald's formula.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011932026N2
Registration date: 2017-04-27, 1396/02/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-27, 1396/02/07
Registrant information
Name
Mahdie Hoseinzade
Name of organization / entity
Shahid Sadoughi University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9110
Email address
hoseinzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Science
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2017-05-31, 1396/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of L carnitine on clinical symptoms, lipid profile and oxidative stress in obese women with knee osteo arthiritis under weight loss diet
Public title
The effect of L carnitine in women with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: women؛ age between 45 to 70؛ Early detection of osteoarthritis؛ body mass index more than25؛ Lack of weight loss diets over the past three months؛ lack of participate in the intervention program the past three months Exclusion: heart disease؛ hypothyroidism؛ rheumatoid arthritis؛ hepatic disease؛kidney disease and knee sergury
Age
From 45 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
in this study will be randomly assigned to 2 groups by using the table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of School of Public Health, Shahid Sadoughi University of Medical Sciences,
Street address
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SSU.SPH.REC.1395.45

Health conditions studied

1

Description of health condition studied
knee osteo arthritis
ICD-10 code
M15.0
ICD-10 code description
Primary generalized (osteo)arthrosis

Primary outcomes

1

Description
pain
Timepoint
before intervention and 12 weeks after the intervention
Method of measurement
womac questionnaire

2

Description
lipid profile(HDL, LDL, TG, Cho)
Timepoint
before intervention and 12 weeks after the intervention
Method of measurement
with special kits

3

Description
CRP
Timepoint
before intervention and 12 weeks after the intervention
Method of measurement
with special kits

4

Description
Malondialdehyde
Timepoint
before intervention and 12 weeks after the intervention
Method of measurement
with special kits

Secondary outcomes

1

Description
waist, Hip circumference.
Timepoint
before intervention and 12 weeks after the intervention
Method of measurement
meter

2

Description
weight, fat mass, free fat mass
Timepoint
before intervention and 12 weeks after the intervention
Method of measurement
Omron digital Scale(BF11)

Intervention groups

1

Description
control group:this group will consume of one tablet(1000mg placebo) one time a day after meals (lunch or breakfast) with weight loss diet for 12 weeks. tablets will produce from Karen Company in Yazd.
Category
Treatment - Drugs

2

Description
intervention group:this group will consume of one tablet(1000mg L carnitine) one time a day after meals (lunch or breakfast) with weight loss diet for 12 weeks. tablets will produce from Karen Company in Yazd.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al-Anbia Super Speciality Clinic
Full name of responsible person
Dr.Ali Dehghan
Street address
Taleghani Street, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of School of Public Health, Shahid Sadoughi University of Medical Scien
Full name of responsible person
Dr Seyed Saeid Mazloomy
Street address
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
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 of School of Public Health, Shahid Sadoughi University of Medical Scien
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
School of Public Health, Shahid Sadoughi University of Medical Sciences,
Full name of responsible person
Farnaz Baghban
Position
master of nutrition/graduate student of Health Sciences in NutritionG
Other areas of specialty/work
Street address
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Postal code
8915173160
Phone
+98 71 3730 5474
Fax
Email
farnaz_baghban@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Mahdie Hoseinzadeh
Position
Assistant Professor/Phd of nutritin
Other areas of specialty/work
Street address
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Postal code
8915173160
Phone
+98 35 3149 2232
Fax
Email
hoseinzade.mahdie@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Public Health, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hassan Mozaffari Khosravi
Position
PhD of nutrition science/ Profesor
Other areas of specialty/work
Street address
School of Public Health, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Postal code
8915173160
Phone
+98 35 3820 9110
Fax
Email
h.mozaffari@ssu.ac.ir
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
Loading...