Protocol summary
-
Study aim
-
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
-
Greetings and Regards
Correction of recruitment start date, recruitment end date, and completion of trial.
Request the removal of tumor necrosis factor due to the very high cost of this kit (more than the total budget of the project) and the addition of renal and liver function, lipid profile and fasting blood sugar tests with lower cost as a secondary outcome. Serum samples have been frozen at -70 and are ready for testing.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20131009014957N6
Registration date:
2019-02-01, 1397/11/12
Registration timing:
prospective
Last update:
2020-05-23, 1399/03/03
Update count:
1
-
Registration date
-
2019-02-01, 1397/11/12
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-02-09, 1397/11/20
-
Expected recruitment end date
-
2020-02-09, 1398/11/20
-
Actual recruitment start date
-
2019-06-05, 1398/03/15
-
Actual recruitment end date
-
2020-04-21, 1399/02/02
-
Trial completion date
-
2020-06-04, 1399/03/15
-
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 uncontrolled 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
Actual sample size reached:
84
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
-
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
-
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
2
-
Description
-
Renal function tests
-
Timepoint
-
Before intervention and 8 weeks after intervention
-
Method of measurement
-
Using biochemical methods
3
-
Description
-
Liver function tests
-
Timepoint
-
Before intervention and 8 weeks after intervention
-
Method of measurement
-
Using biochemical methods
4
-
Description
-
ُSerum lipid profile
-
Timepoint
-
Before intervention and 8 weeks after intervention
-
Method of measurement
-
Using biochemical methods
5
-
Description
-
Fasting blood sugar
-
Timepoint
-
Before intervention and 8 weeks after intervention
-
Method of measurement
-
Using biochemical methods
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
1
-
Sponsor
-
-
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
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.
-
Comments
-