The effect of oral capsule curcumin and vitamin E in comparison to placebo on serum levels of some antioxidants and inflammatory factors in postmenopausal women: A randomized, triple-controlled clinical trial.
Determination of the effect of curcumin and vitamin E in comparison with placebo on serum levels of some antioxidants and inflammatory factors in postmenopausal women
Design
En Randomized controlled clinical trial with three parallel arms.
Settings and conduct
This is a randomized, triplicate randomized controlled triplicate study on 93 postmenopausal women in Tabriz.Sampling in three different health centers will be done in terms of socioeconomic status. At before the intervention and after the intervention, after about 12 hours of fasting in the laboratory, the researcher 5 cc blood was taken and in three separate tubes with 3000 rpm in a minute for centrifugation at -70 ° C Centimeters will be kept until the tests are performed, the second time after the intervention, and the Total Antioxidant Capacity TAC, MDA, high sensitivity (hsCRP C-Reactive Protein), TNF-α (Tumor Necrosis Factor. Contributors will be assigned randomized blocking with a 1: 1: 1 assignment ratio to three groups (two intervention groups and one control group).
Participants/Inclusion and exclusion criteria
Participants in postmenopausal women aged 40 to 60 years who score at least 15 and a maximum of 42 in the Green Questionnaire have hot flash symptoms.
Intervention groups
The first intervention group received 500 mg capsicum capsules twice daily for up to eight weeks, the second intervention group received 200 IU of oral Capsules twice daily for eight weeks, and the third group receiving the control group will receive a placebo.
Main outcome variables
1) Mean serum levels of MDA and TAC in postmenopausal women 2) Mean serum levels of hsCRP and TNF-α levels in postmenopausal women 3) Mean score of menopausal symptoms and its subtypes in postmenopausal women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131009014957N6
Registration date:2019-02-01, 1397/11/12
Registration timing:prospective
Last update:2019-02-01, 1397/11/12
Update count:1
Registration date
2019-02-01, 1397/11/12
Registrant information
Name
Azizeh Farshbaf-khalili
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 9151
Email address
farshbafa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral capsule curcumin and vitamin E in comparison to placebo on serum levels of some antioxidants and inflammatory factors in postmenopausal women: A randomized, triple-controlled clinical trial.
Public title
The effect of oral capsule curcumin and vitamin E in comparison to placebo on serum levels of some antioxidants and inflammatory factors in postmenopausal women: A randomized, triple-controlled clinical trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Readiness to participate in the study
2) Having sufficient literacy to complete the questionnaire or the presence of a literate person in the family
3) has normal menopause
4) Women who are less than 6 years old from their menopause.
5) having at least 40 years and a maximum of 60
6)Earn a minimum score of 15 and a maximum of 42 in the Green AssessmentHot flashes
Exclusion criteria:
1) Use of tobacco and alcohol and herbal medicines
2) Stress factors such as the death of first-degree relatives in the last 6 months and the loss of a job
3) Any acute and chronic inflammatory disease (including diabetes, rheumatoid arthritis) and infections in the body
4) The presence of malignant disease
5) History of recent surgery and trauma
6) History of allergy to turmeric or other drugs, food and color.
7) taking anticoagulants (heparin, varfarin, enoxaparin)
8) Take vitamin E supplementation, curcumin or estrogen therapy for 3 months prior to study
9) Use of special diets
Age
From 40 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned randomly blocked blocks with 6 and 9 blocks and 1: 1: 1 assignment to three groups (two intervention groups and one control group) using RAS software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To hide the allocation, the same black, opaque, and back-numbered glasses (assignment sequences) inside them, either the curcumin capsule or the vitamin E capsule or the placebo capsule, will be used to hide the allocation. Preparation of glasses by an unoccupied person will be done in sampling and collecting data and analyzing them according to the assignment sequence. The first person will be in the condition of glass No. 1 and will continue until the sampling is completed. In all three groups, stratification based on BMI will be done alik
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department., third floor., central construction number 2., Tabriz University of Medical Sciences., Golgasht Street., Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.TBZMED.REC.1397.674
Health conditions studied
1
Description of health condition studied
TAC (Total Antioxidant Capacity)
ICD-10 code
ICD-10 code description
2
Description of health condition studied
(Malondialdehyde) MDA
ICD-10 code
ICD-10 code description
3
Description of health condition studied
hsCRP (high sensitivity C-Reactive Protein)
ICD-10 code
ICD-10 code description
4
Description of health condition studied
TNf-α (Tumor Necrosis Factor )
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Early symptoms of manopause
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
(Total Antioxidant Capacity) TAC
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
TAC levels will be measured with the Biorex kit.
2
Description
(Malondialdehyde) MDA
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Spectrophotometric and Atomic Absorption Comparison (AAS) will be measured.
3
Description
hsCRP (high sensitivity C-Reactive Protein)
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
A turbidometric method based on the formation of a complex resulting from the reaction between hs-CRP and its specific antiserum will be measured.
4
Description
TNf-α (Tumor Necrosis Factor )
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
TNF-α from its own etiology kits will be measured by a laboratory expert at the Pharmaceutical Application Research Center.
5
Description
Score of Menopause symptoms and its sub-scales.
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Green Questionnaire
Secondary outcomes
1
Description
Food intake
Timepoint
Before the intervention, one month after the intervention and at the end of the intervention
Method of measurement
24-hour Food record
Intervention groups
1
Description
Intervention group: The first Intervention group will receive oral capsules of curcumin twice a day at a dose of 500 milligrams for eight weeks
Category
Treatment - Drugs
2
Description
Intervention group:The second intervention group will receive oral Capsule Vitamin E 200 IU twice a day for eight weeks.
Category
Treatment - Drugs
3
Description
Control group: The control group will receive placebo capsules twice a day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers selected in Tabriz
Full name of responsible person
Dr. Azizeh Farshbaf Khalili
Street address
Faculty of Nursing and Midwifery., South Shariati St., Tabriz., Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3479 6770
Email
Farshbafa@tbzmed.ac.ir
Web page address
http://tabriz-phc.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research department., third floor., central construction number 2., Tabriz University of Medical Sciences., Golgasht Street., Azadi Avenue., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Azizeh Farshbaf Khalili
Position
Assistant Professor of Tabriz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nursing Midwifery., South Shariati Street., Tabriz., Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5155884818
Phone
+98 41 3479 6770
Email
Farshbafa@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Azizeh Farshbaf Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
Farshbafa@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Azizeh Farshbaf Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
Farshbafa@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
he results of the clinical study will be published as a paper.
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article.
From where data/document is obtainable
Farshbafa@tbzmed.ac.ir
What processes are involved for a request to access data/document
Maximum one week after the communication by email.