Eeffect of oral administration of N- acetyl cysteine on decrease of oxidative stress , Concentration of heavy metals and lipid profile in Women with Endometriosis
Evaluation of oral N-acetylcysteine administration on reduction of oxidative stress, heavy metal concentration and serum lipid profile in women with endometriosis
Design
This is a parallel, non-blinded, randomized controlled clinical trial
Settings and conduct
this study will be done at the Fatemezahra Infertility Center of Babol University of Medical Sciences. Sixty women with endometriosis will be divided into two groups (30 in each group), intervention group will be received routine treatment with n-acetylcysteine and comparison group received routine treatment. Index of lipid peroxidation, total antioxidant capacity and carbonyl will be measured. Determination of iron and lactate dehydrogenase in blood samples of patients by spectrophotometric method and determination of 8-hydroxy-2-doxy guanosine as an indicator of DNA oxidative stress by ELISA and heavy metals by atomic absorption and lipid indices Spectrophotometry will be performed.
Participants/Inclusion and exclusion criteria
Endometriosis, 20-45 years old, obesity , not taking antioxidants and non-clinical, or surgical treatment in the past 6 months, no chronic diseases such as: hepatitis, thalassemia anemia, diabetes , infectious diseases and Inflammatory.
Intervention groups
The experimental group will receive routine treatment and a 6-week oral administration of N-acetylcysteine at a daily dose of 8.1 g daily (3 g daily for obese women). The control group will receive only routine treatment.
Main outcome variables
Malondialdehyde, lactate dehydrogenase, total antioxidant capacity, zinc, copper, lead, cadmium, nickel, chromium and lipid indices.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100411003684N9
Registration date:2020-01-27, 1398/11/07
Registration timing:registered_while_recruiting
Last update:2020-01-27, 1398/11/07
Update count:1
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Soleiman Mahjoub
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0569
Email address
s.mahjoub@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for research of Babol University of Medical Sciences
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Eeffect of oral administration of N- acetyl cysteine on decrease of oxidative stress , Concentration of heavy metals and lipid profile in Women with Endometriosis
Public title
Eeffect of oral administration of N- acetyl cysteine in Women with Endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with endometriosis
َAge 20-45 years old
Laparoscopic diagnosis of endometriosis
Not taking antioxidant supplements
Lack of chronic diseases such as: diabetes- hepatitis- thalassemia anemia-infectious and inflammatory diseases
No clinical or surgical treatment for the past six months
Lack of polycystic ovary
Exclusion criteria:
Non-use of medication
Thalassemia. Diabetes- Hepatitis- Anemia-Infectious and Inflammatory diseases.
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences
City
Babol
Province
Tehran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
MUBABOL.HRI.REC.1393.1671
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80.8
ICD-10 code description
Other endometriosis
Primary outcomes
1
Description
Malondialdehyde (MDA)
Timepoint
6 Weeks
Method of measurement
TBARS Method (Spectrophotometry)
2
Description
Total antioxidant capacity (TAC)
Timepoint
6 Weeks
Method of measurement
FRAP Method
3
Description
Blood Iron
Timepoint
6 Weeks
Method of measurement
Spectrophotometry
4
Description
Lactate dehydrogenase (LDH)
Timepoint
6 Weeks
Method of measurement
Spectrophotometry
5
Description
8-OH-2-deoxy-Guanosine (8-OHdG)
Timepoint
6 Weeks
Method of measurement
ELISA
6
Description
Carbonyl
Timepoint
6 Weeks
Method of measurement
Levin Method
7
Description
DPPH index
Timepoint
6 Weeks
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Levels of Lead
Timepoint
6 week
Method of measurement
Atomic absorption
2
Description
Levels of cadmium
Timepoint
6 Week
Method of measurement
Atomic absorption
3
Description
Levels of nickel
Timepoint
6 Week
Method of measurement
Atomic absorption
4
Description
Levels of chromium
Timepoint
6 Week
Method of measurement
Atomic absorption
5
Description
Levels of High Density Lipoprotein (HDL)
Timepoint
6 Week
Method of measurement
Spectrophotometer
6
Description
Levels of Low Density Lipoprotein (LDL)
Timepoint
6 Week
Method of measurement
Spectrophotometer
7
Description
Levels of Triglyceride
Timepoint
6 Week
Method of measurement
Spectrophotometer
8
Description
Levels of Cholesterol
Timepoint
6 Week
Method of measurement
Spectrophotometer
9
Description
Levels of Cu
Timepoint
6 Week
Method of measurement
Spectrophotometer
10
Description
Levels of Zn
Timepoint
6 Week
Method of measurement
Spectrophotometer
11
Description
Levels of Zn
Timepoint
6 Week
Method of measurement
Spectrophotometer
12
Description
Level of Carbonyl
Timepoint
6 Week
Method of measurement
Spectrophotometer
13
Description
DPPH Index
Timepoint
6 Week
Method of measurement
Spectrophotometer
Intervention groups
1
Description
Oral administration of N- acetyl cysteine with dose of 1/8 gr/day (overweight women 3 gr/day) during 6 weeks in addition to routine medication in women with endometriosis.
Category
Treatment - Drugs
2
Description
The control group will be received routine medication.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and Reproductive Health Research Center
Full name of responsible person
Dr Sadighe Esmaeilzadeh
Street address
Infertility and Reproductive Health Research Center, Fatemeh Zahra Hospital, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3227 4882
Email
sesmael2010@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Babol-Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0557
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
913438
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Prof. Soleiman Mahjoub
Position
Academic member
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0569
Fax
Email
smahjoub20@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Prof. Soleiman Mahjoub
Position
Academic member
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, Babol University of Medical Sciences, Babol