1. Home
  2. Approved trials
  3. » فارسی

The assessment of the effect of L-carnitine supplementation versus placebo on serum total antioxidant and oxidant capacities, lipid profile in patients with pemphigus vulgaris

Protocol summary

Summary
This study will be done as a double blind placebo controlled clinical trial on 52 patients with 30 to 65 years old affected by pemphigus vulgaris. The patients presenting to RAZI hospital who affected to the illness at least one year and using Prednisolone will be under study in order to determine the influences of L-carnitine supplementation to the total antioxidant and oxidative capacities, serum lipid profiles, psychological status, fatigue and quality of life. Patients will be divided in two groups according to permuted block randomization by using random code receive 1000 mg of L-carnitine or placebo tablets twice a day. The duration of this intervention is 8 weeks; at the beginning and end of the study, 10 cc blood will be taken from patients for measuring the serum concentration of fasting blood glucose, triglycerides, total cholesterol, HDL, LDL, VLDL, TAC, TOC, F2isoprostane and L-carnitine. The dietary data of the patients also will be collected by a 24-h dietary recall for three days (one holiday day and two usual days) at the beginning and end of the study. Also SF-36, GHQ-12, FSS and DLQI questionare will be taken at the beginning and end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062322769N4
Registration date: 2015-08-13, 1394/05/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-08-13, 1394/05/22
Registrant information
Name
Mohammad Hassan Javanbakht
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8891 4462
Email address
mhjavan@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of medical sciences; school of nutritional sciences and dietetics
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-09, 1394/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of the effect of L-carnitine supplementation versus placebo on serum total antioxidant and oxidant capacities, lipid profile in patients with pemphigus vulgaris
Public title
The effect of L-carnitine in the treatment of complications of patients with pemphigus vulgaris
Purpose
Prevention
Inclusion/Exclusion criteria
INCLUSION CRITERIA: Willingness to cooperate; Affected by pemphigus vulgaris; Minimum one year of pemphigus vulgaris illness; Using Corticosteroid alone or with one of the Methotrexate, Azathioprine and Cellcept drugs; Age between 30 and 65 years old; BMI<35; Lack of Cardiovascular disease, renal, hepatic and inflammatory intestinal diseases; No alcohol consumption; Do not use of any antioxidant supplementation during the last 3 months; No consumption of Cisplatin, Theophylline and Valproate during the past month; Non-smoking and tobacco use (People who have smoked less than five cigarettes daily in previous 6 months); Lack of pregnancy and lactation EXCLUSION CRITERIA: Changing the type of used drug; Find allergy symptoms at any time of the study
Age
From 30 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
For double blinding the study, all boxes of l-carnitine and placebo tablets will be divided in two groups of 1 and 2 by someone other than researcher. The researcher, physician and the patient will be unaware of this group division. This group division will be done based on a random numbers table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sixth Floor, Central department of University, Ghods St., Keshavarz Blvd.
City
tehran
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
IR.TUMS.REC.1394.28

Health conditions studied

1

Description of health condition studied
pemphigus vulgaris
ICD-10 code
L10.0
ICD-10 code description
Pemphigus vulgaris

Primary outcomes

1

Description
L-carnitine
Timepoint
Before and 8 weeks after intervention
Method of measurement
Through the serum by ELISA kit

2

Description
Osteopentin
Timepoint
Before and 8 weeks after intervention
Method of measurement
Through the serum by ELISA kit

3

Description
Total oxidant capacity
Timepoint
Before and 8 weeks after intervention
Method of measurement
Through the serum by ELISA kit

4

Description
F2isoprostane
Timepoint
Before and 8 weeks after intervention
Method of measurement
Through the serum by ELISA kit

5

Description
Total cholesterol
Timepoint
Before and 8 weeks after intervention
Method of measurement
Through the serum by colorimetric

6

Description
Triglycerides
Timepoint
Before and 8 weeks after intervention
Method of measurement
Through the serum by colorimetric

7

Description
Low-density lipoprotein
Timepoint
Before and 8 weeks after intervention
Method of measurement
Through the serum by colorimetric

8

Description
High-density lipoprotein
Timepoint
Before and 8 weeks after intervention
Method of measurement
Through the serum by colorimetric

9

Description
Fasting Blood sugar
Timepoint
Before and 8 weeks after intervention
Method of measurement
Through the serum by colorimetric

10

Description
Added at 2017-08-08:bone morphogenic protein 4
Timepoint
Added at 2017-08-08: Before and 8 weeks after intervention
Method of measurement
Added at 2017-08-08: Through the serum by ELISA kit

11

Description
Added at 2017-08-08: cystatin c
Timepoint
Added at 2017-08-08: Before and 8 weeks after intervention
Method of measurement
Added at 2017-08-08: Through the serum by ELISA kit

12

Description
Added at 2017-10-05: HOMA-IR
Timepoint
Added at 2017-10-05: Before and 8 weeks after intervention
Method of measurement
Added at 2017-10-05: Serum concentration using ELISA kit

13

Description
Added at 2017-10-05: SFRP5
Timepoint
Added at 2017-10-05: Before and 8 weeks after intervention
Method of measurement
Added at 2017-10-05: Serum concentration using ELISA kit

14

Description
Added at 2017-10-05: Visfatin
Timepoint
Added at 2017-10-05: Before and 8 weeks after intervention
Method of measurement
Added at 2017-10-05: Serum concentration using ELISA kit

15

Description
Added at 2017-10-05: Omentin
Timepoint
Added at 2017-10-05: Before and 8 weeks after intervention
Method of measurement
Added at 2017-10-05: Serum concentration using ELISA kit

Secondary outcomes

1

Description
Quality of life
Timepoint
at the beginning and at the end of the study
Method of measurement
SF-36, GHQ-12, FSS and DLQI questionares

2

Description
Added at 2017-10-05: QUICKI
Timepoint
Added at 2017-10-05: Before and 8 weeks after intervention
Method of measurement
Added at 2017-10-05: Serum concentration using ELISA kit

3

Description
Added at 2017-10-05: Insulin
Timepoint
Added at 2017-10-05: Before and 8 weeks after intervention
Method of measurement
Added at 2017-10-05: Serum concentration using ELISA kit

Intervention groups

1

Description
The use of pill type L-carnitine supplement produced by KAREN chemistry company in 1000 mg dose twice a day (morning and evening) for 8 weeks
Category
Treatment - Drugs

2

Description
The use of pill type placebo produced by KAREN chemistry company in 1000 mg dose twice a day (morning and evening) for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Razi skin
Full name of responsible person
Mohamad Hasan Javanbakht/PHD Nutrition/Assistant Professor and Faculty member of School of Nutrition
Street address
HAFEZ St., VAHDAT ESLAMI Ave., VAHDAT ESLAMI Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Sixth Floor, Central department of University, Ghods St., Keshavarz Blvd.
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, Tehran 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
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Hasan Javanbakht
Position
PHD Nutrition/Assistant Professor and Faculty member of School of Nutritional Sciences and Dietetics
Other areas of specialty/work
Street address
No. 44, Hojatdost Alley, Naderi St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8898 5908
Fax
Email
mhjavan2001@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Hasan Javanbakht
Position
PHD Nutrition
Other areas of specialty/work
Street address
No. 44, Hojatdost Alley, Naderi St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8898 5908
Fax
Email
mhjavan2001@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Hasan Javanbakht
Position
PHD Nutrition/Assistant Professor and Faculty member of School of Nutritional Sciences and Dietetics
Other areas of specialty/work
Street address
No. 44, Hojatdost Alley, Naderi St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8898 5908
Fax
Email
mhjavan2001@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
Loading...