The purpose of this project is to investigate the changes in gene expression in patients with polycystic ovary syndrome and to integrate it with molecular docking to identify dietary supplements that can impact the function of these genes.
Design
This is a before-after single-arm clinical trial study. Thirty women with polycystic ovary syndrome and Thirty healthy women will receive 2000 IU daily of Vitamin D under the same monitoring protocol to evaluate its effect on gene expression changes of gene(s) of interest.
Settings and conduct
First, microarray or RNA Seq data from PCOS patients is analyzed. The protein structure of Differentially expressed genes (DEGs) and the chemical structure of food supplements are obtained from the relevant database, and their docking is assessed using appropriate software.
The gene or genes that bind to the identified food supplement with the lowest amount of energy are selected. After completing the informed consent form and the questionnaire of PCOS patients and healthy control group referring to Isfahan Shariati Hospital, 5 cc of blood will be taken before and after 8 weeks. The expression changes of the gene or candidate genes are evaluated. At the end, the data extracted from the questionnaire and the expression data are compared and analyzed using related software.
Participants/Inclusion and exclusion criteria
Patients with PCOS (new cases) and healthy individuals diagnosed by a gynecologist will be included in the study. Pregnant women, menopausal individuals, those who have had a hysterectomy or oophorectomy, or have used OCP or any food supplements will be excluded.
Intervention groups
Women with PCOS and controls will be receive a specific dosage of a
candidate nutritional supplement (Vit D).
Main outcome variables
Expression changes of the target genes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240407061432N1
Registration date:2024-04-17, 1403/01/29
Registration timing:prospective
Last update:2024-04-17, 1403/01/29
Update count:0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
Shahram Nekoeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3237 1103
Email address
nekoeian.sh@res.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Integration of transcriptome and molecular docking to identify effective nutritional supplements in the treatment of polycystic ovary syndrome
Public title
Effect of nutritional supplements in the treatment of polycystic ovary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Woman aged 18-40 with PCOS confirmed by a gynecologist (new case)
Exclusion criteria:
Pregnant women
Menopausal women
Women who underwent oophorectomy or hysterectomy
Women using oral contraceptive pills (OCP)
Women who previously used dietary supplements
Lack of interest in study participation
Age < 18 years
Age > 40 years
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Blood sampling before and after dietary supplement (Vitamin D) intake.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan university of medical sciences - Alzahra Research Centers
Street address
Cancer Prevention Research Center, Seyyed Al Shohada (Omid) Hospital, Mottahari St., Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8184917354
Approval date
2024-03-17, 1402/12/27
Ethics committee reference number
IR.ARI.MUI.REC.1402.348
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome (PCOS)
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
The ratio of changes in target gene expression
Timepoint
Gene expression measured at the beginning of the study (before the intervention) and 2 months after starting the candidate food supplement (Vit D).
Method of measurement
Real- Time RT-PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2000 units of vitamin D from Dana Pharma are prescribed for women recently diagnosed with PCOS and no history of supplement or drug use. They are asked to consume to take one unit daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: 2000 units of vitamin D from Dana Pharma are prescribed to people who have not taken vitamin D in the last three months. And they are asked to consume one unit daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shariati Hospital
Full name of responsible person
Hamid Maghareh Dehkordi
Street address
Dr. Shariati Hospital, Chahar Bagh Bala St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3627 2001
Email
shariati_isf.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza asgari
Street address
Building No.4, Extension, Research and Technology Vice-Chancellor., Hazar Jarib St., Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
Grant name
Isfahan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shahram Nekoeian
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Cancer Prevention Research Center, Seyyed alshohada (Omid) Hospital, Mottahari St.
City
Esfahan
Province
Isfehan
Postal code
81849-17354
Phone
+98 31 3237 1103
Email
Nekoeian_sh@yahoo.com
Web page address
https://cprc.mui.ac.ir/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahram Nekoeian
Position
Research associate
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Cancer Prevention Research Center, Seyyed Al Shohada (Omid) Hospital, Mottahari St
City
Esfafahn
Province
Isfehan
Postal code
81849-17354
Phone
+98 31 3237 1103
Email
nekoeian.sh@res.mui.ac.ir
Web page address
https://cprc.mui.ac.ir/fa
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahram nekoiean
Position
Research associate
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Cancer Prevention Research Center, Omid Hospital, Mottahari St.
City
Esfahan
Province
Isfehan
Postal code
81849-17354
Phone
+98 31 3237 1103
Email
nekoeian_sh@yahoo.com
Web page address
https://cprc.mui.ac.ir/fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Re-analysis of data obtained from databases and expression changes of the effect of vitamin D on genes of patients and healthy individuals will be provided to researchers without providing individual details.
When the data will become available and for how long
The data access period will be 6 months after the publication of the results.
To whom data/document is available
Academic /Research centers professors
Under which criteria data/document could be used
Researchers can refer to the published article and use the reanalysis of primary data of transcriptome and molecular docking.
From where data/document is obtainable
Data can be received through the project manager (Dr. Shahram Nekoeian) and the academic address Nekoeian.sh@res.mui.ac.ir using the academic email.
What processes are involved for a request to access data/document
The data will be provided to the applicant within 1 week after receiving the university email and obtaining the necessary permission.