- 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
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.