Protocol summary

Study aim
Objective: The aim of this study is to determine the effects of combined probiotic and vitamin D supplementation on hormonal profiles, inflammatory factors and oxidative stress biomarkers in patients with polycystic ovary syndrome
Design
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive combined vitamin D and probiotic supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with polycystic ovarian syndrome referred to Shabihkhani Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. 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. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate
Intervention groups
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally. Control group: Probiotic and vitamin D placebo capsules (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally.
Main outcome variables
Outcomes: Total testosterone (primary outcome) and biomarkers of inflammation, oxidative stress and mental health parameters (secondary outcomes) will be quantified at study baseline and end-of-trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT20170513033941N37
Registration date: 2018-08-18, 1397/05/27
Registration timing: retrospective

Last update: 2018-08-18, 1397/05/27
Update count: 0
Registration date
2018-08-18, 1397/05/27
Registrant information
Name
Vahidreza Ostadmohammadi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-02, 1397/04/11
Expected recruitment end date
2018-07-16, 1397/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of combined probiotic and vitamin D supplementation on hormonal profiles, inflammatory factors and oxidative stress biomarkers in women with polycystic ovary syndrome
Public title
Effect of combined probiotic and vitamin D supplementation in the treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with polycystic ovary syndrome Individuals aged 18 to 40 years.
Exclusion criteria:
Exclusion criteria: Individuals with neoplastic disorders cardiovascular diseases malabsorptive disorders current or previous (within the last 6 months) use of hormonal; antidiabetic and anti-obesity medications.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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 Shabihkhani clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of National Institute for Medical Research Development of Iran (NIMAD)
Street address
National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran
City
Tehran
Province
Isfehan
Country
Iran (Islamic Republic of)
Postal code
1419693111
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.NIMAD.REC.1397.205

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
Total testosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

Secondary outcomes

1

Description
SHBG
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

2

Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

3

Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

4

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

5

Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

6

Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

7

Description
Beck Depression Inventory
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire

8

Description
General Health Questionnaire
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire

9

Description
DASS
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Probiotic and vitamin D placebo capsules (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shabihkhani Clinic
Full name of responsible person
Mansoreh Samimi
Street address
Shahid Beheshti Avenue, Kashan
City
Kashan
Province
Isfehan
Country
Iran (Islamic Republic of)
Postal code
8115187159
Phone
+98 31 4446 0180
Email
samimi_m@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Institute for Medical Research Development of Iran (NIMAD)
Full name of responsible person
Dr. Reza Malekzadeh
Street address
National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran
City
Tehran
Province
Tehran
Country
Iran (Islamic Republic of)
Postal code
1419693111
Phone
+98 21 6693 8037
Email
malek@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development of Iran (NIMAD)
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
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Country
Iran (Islamic Republic of)
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Country
Iran (Islamic Republic of)
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Country
Iran (Islamic Republic of)
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
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
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