The effects of combined probiotic and vitamin D supplementation on metabolic profiles in women with polycystic ovary syndrome

Objective: The aim of this study is to determine the effects of combined probiotic and vitamin D supplementation on metabolic profiles in women 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).

Among patients with polycystic ovarian syndrome referred to Alavi Clinic affiliated to Ardabil 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.

nclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.

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.

Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.

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.

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Alavi 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