Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of combined probiotic and vitamin D supplementation on metabolic profiles in patients with polycystic ovary syndrome
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Design
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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).
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Settings and conduct
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Among patients with polycystic ovarian syndrome referred to Naghavi outpatient Clinic , 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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Pregnancy, lactation, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes, psychological disorders.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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correction
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170513033941N37
Registration date:
2018-08-18, 1397/05/27
Registration timing:
retrospective
Last update:
2019-10-11, 1398/07/19
Update count:
2
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Registration date
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2018-08-18, 1397/05/27
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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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2018-07-02, 1397/04/11
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Expected recruitment end date
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2018-07-23, 1397/05/01
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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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The effects of combined probiotic and vitamin D supplementation on hormonal profiles, inflammatory factors and oxidative stress biomarkers in women with polycystic ovary syndrome
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Public title
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Effect of combined probiotic and vitamin D supplementation in the treatment of polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Patients with polycystic ovary syndrome
Individuals aged 18 to 40 years.
Exclusion criteria:
Pregnant women
Lactation
Adrenal hyperplasia
Androgen-secreting tumors
Hyperprolactinemia
Thyroid dysfunction
Diabetes
Psychological or psychiatric disorders such as anxiety or depressive symptoms at the enrollment
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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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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To decrease potential confounding effects, all participants will have balanced randomisation. Then, participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi outpatient 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
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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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2018-07-01, 1397/04/10
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Ethics committee reference number
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IR.NIMAD.REC.1397.205
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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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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Total testosterone
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
Secondary outcomes
1
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Description
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SHBG
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
3
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
4
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
5
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
7
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Description
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Beck Depression Inventory
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
8
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Description
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General Health Questionnaire
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
9
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Description
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DASS
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
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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Yes
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Title of funding source
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National Institute for Medical Research Development of Iran (NIMAD)
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available