Evaluating the effect of sulforaphane supplementation in women with Polycystic ovary syndrome (PCOS) on depression, insulin resistance, and lipid profile change
Evaluating the effect of sulforaphane supplementation in women with Polycystic ovary syndrome (PCOS) on depression, insulin resistance, and lipid profile change
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
This study will be performed among women with PCOS who refer to the gynecology clinic of Arash Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of PCOS according to Rotterdam - Mild to moderate depression - 18-40 years old - BMI = or > 25 - High blood fat - Disruption of Glucose tolerance test. Exclusion criteria: Smoking - Lactation or gestation - Metabolic or thyroid dysfunction - Hyperprolactinemia - Hypercortisolemia - Severe depression - CNS drugs used such as antidepressants or anxiolytics - Insulin administration - Uncontrolled blood glucose level - Intense physical activity - History of severe stress - Emotional failure or hospitalization in recent past - History of mental health problems in first-degree relatives
Intervention groups
Intervention group: Women with PCOS take sulforaphane twice a day for 12 weeks. Control group: Women with PCOS take placebo twice a day for 12 weeks.
Main outcome variables
Severity of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N144
Registration date:2022-06-26, 1401/04/05
Registration timing:prospective
Last update:2022-06-26, 1401/04/05
Update count:3
Registration date
2022-06-26, 1401/04/05
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
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
Evaluating the effect of sulforaphane supplementation in women with Polycystic ovary syndrome (PCOS) on depression, insulin resistance, and lipid profile change
Public title
The effect of sulforaphane on depression in women with PCOS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of PCOS according to Rotterdam
Mild to moderate depression
18-40 years old
BMI = or > 25
High blood fat
Disruption of Glucose tolerance test
Exclusion criteria:
Smoking
Lactation or gestation
Metabolic or thyroid dysfunction
Hyperprolactinemia
Hypercortisolemia
Severe depression
CNS drugs used such as antidepressants or anxiolytics
Insulin administration
Uncontrolled blood glucose level
Intense physical activity
History of severe stress
Emotional failure or hospitalization in recent past
History of mental health problems in first-degree relatives
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups).
The best way to create randomization is to use random allocation. Random allocation in clinical trial studies refers to the process of randomly dividing participants into different groups. Randomization gives each participant an equal chance to participate in each group. Successful randomization requires that researchers and study participants be unable to predict the type of intervention received.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine Ethics Committee, Tehran University of Medical Sciences
Street address
School of Medicine, Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-03-28, 1401/01/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.157
Health conditions studied
1
Description of health condition studied
Severity of depression
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline and weeks 6 & 12
Method of measurement
By Hamilton Depression Rating Scale (HDRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women with PCOS take sulforaphane 30 mg twice a day for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Women with PCOS take placebo twice a day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
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
Yes - There is 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
Yes - There is 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
The data will be distributed through final report
When the data will become available and for how long
5 years from 2023 to 2028
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Users should cite the resource of data
From where data/document is obtainable
Prof Shahin Akhondzadeh
What processes are involved for a request to access data/document