Protocol summary
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Study aim
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Evaluating the effect of sulforaphane supplementation in women with Polycystic ovary syndrome (PCOS) on depression, insulin resistance, and lipid profile change
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Design
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Randomized double blind and placebo-controlled clinical trial
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Settings and conduct
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This study will be performed among women with PCOS who refer to the gynecology clinic of Arash Hospital
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Severity of depression
General information
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Reason for update
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Length of time to complete the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090117001556N144
Registration date:
2022-06-26, 1401/04/05
Registration timing:
prospective
Last update:
2026-06-03, 1405/03/13
Update count:
3
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Registration date
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2022-06-26, 1401/04/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-23, 1401/06/01
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Expected recruitment end date
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2025-10-02, 1404/07/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of sulforaphane supplementation in women with Polycystic ovary syndrome (PCOS) on depression, insulin resistance, and lipid profile change
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Public title
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The effect of sulforaphane on depression in women with PCOS
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-03-28, 1401/01/08
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1401.157
Health conditions studied
1
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Description of health condition studied
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Severity of depression
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Severity of depression
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Timepoint
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Baseline and weeks 4, 8, & 12
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Method of measurement
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By Hamilton Depression Rating Scale (HDRS)
Intervention groups
1
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Description
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Intervention group: Women with PCOS take sulforaphane 15 mg twice a day for 12 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Women with PCOS take placebo twice a day for 12 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The data will be distributed through final report
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When the data will become available and for how long
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5 years from 2023 to 2028
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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Users should cite the resource of data
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From where data/document is obtainable
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Prof Shahin Akhondzadeh
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What processes are involved for a request to access data/document
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By E-mail
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Comments
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