The aim of this study is to determine the effects of spirulina supplementation on metabolic profile and clinical manifestation in women with polycystic ovary syndrome (PCOS).
Design
Clinical trial with control group, parallel groups, double-blind (both patients and researchers), randomized, 60 women with PCOS, phase 2
Settings and conduct
Population and sample size: 60 women with PCOS eligible and referred to Gynecology Clinic (Shahid Beheshti hospital) affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. Time of intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome according to Rotterdam criteria and aged 25 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention group: 500 mg spirulina oral capsule, twice a day, for 12 weeks. Control group: Placebo oral capsule contain starch, twice a day, for 12 weeks.
Main outcome variables
Clinical symptoms and Fasting plasma glucose (primary outcome) and Total cholesterol, Triglycerides and HDL (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230122057180N1
Registration date:2023-01-24, 1401/11/04
Registration timing:prospective
Last update:2023-01-24, 1401/11/04
Update count:0
Registration date
2023-01-24, 1401/11/04
Registrant information
Name
Elahe Heydarian fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
heydarianfard-e@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of spirulina supplementation on metabolic profile and clinical manifestation in women with polycystic ovary syndrome
Public title
Effect of spirulina in treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovary syndrome according to Rotterdam criteria
Women aged 25-40 years
Complete informed consent
Exclusion criteria:
Hyperprolactinemia
Thyroid disorders
Subjects following a special diet or consuming drugs with an effect on hormonal profile like oral conceptives (OCP)
Steroid hormones, or any other drugs probably to affect ovarian action in the last 3 months
Type 2 diabetes mellitus (T2DM)
Cushing’s syndrome
Smokers
Unwillingness to cooperate
Age
From 25 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. Supplements and placebos are only the code is written on the packages. Patients and researcher do not know the type of intervention and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Faculty of Medicine & Dentistry- Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2022-09-04, 1401/06/13
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.106
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Clinical symptoms
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire PCOS (Based on NIH criteria)
2
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: 500 mg spirulina oral capsule (Khalije Fars Biotechnology Development Company, Tehran-Iran), twice a day, for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo oral capsule contain starch (Khalije Fars Biotechnology Development Company, Tehran- Iran), twice a day, for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic (Shahid Beheshti hospital)
Full name of responsible person
Fatemeh Foroozanfard
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
forozanfar_f@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
hamidi.gholamali2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Elahe Heydarianfard
Position
Resident of obstetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Email
elahe_heydarianfard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Foroozanfard
Position
Obstetricians
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5544 7619
Email
forozanfar_f@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Elahe Heydarianfard
Position
Resident of obstetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Email
elahe_heydarianfard@yahoo.com
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
Dr. Elahe heydarianfard is committed to presenting all the achievements of the project in accordance with the framework of the National Institute for Medical Research Development in the Islamic Republic of Iran.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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