Plain language summary
Polycystic ovary syndrome (PCOS) is a common cause of female infertility. Whilst the exact cause of PCOS is not known, high levels of male hormones, inflammation and oxidative damage are thought to contribute to the development of PCOS. Both probiotics and vitamin D supplements have been demonstrated to have anti-inflammatory and anti-oxidant effects. The aim of this study was to determine the effect of combined vitamin D and probiotic supplementation on mental health, hormonal, inflammatory and oxidative stress parameters in women with PCOS. This randomised, double-blinded, placebo-controlled clinical trial was carried out on 60 women with PCOS aged 18-40 years old in Iran. The women were randomly allocated to take either 50,000 IU vitamin D every 2 weeks plus 8 × 109 CFU/day probiotic or a placebo for 12 weeks. The probiotic capsule contained four strains: Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus reuteri and Lactobacillus fermentum (2 × 109 CFU/g each). Vitamin D and probiotic supplementation significantly improved mental health and general health scores, compared with the placebo. Vitamin D and probiotic supplementation was associated with a significant reduction in total testosterone (mean reduction of 0.19 ng/mL), excess body/facial hair, high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde (MDA) levels, and a significant increase in total antioxidant capacity (TAC) and total glutathione (GSH) levels, compared with the placebo. Vitamin D and probiotic supplementation did not affect serum sex-hormone binding globulin (SHBG) or nitric oxide levels. There were no effects on acne or alopecia. The authors concluded that the co-administration of vitamin D and probiotic for 12 weeks to women with PCOS had beneficial effects on mental health parameters, serum total testosterone, hirsutism, hs-CRP, plasma TAC, GSH and MDA levels
Abstract
OBJECTIVE The aim of this study was to determine the effect of vitamin D and probiotic co-administration on mental health, hormonal, inflammatory and oxidative stress parameters in women with polycystic ovary syndrome (PCOS). METHODS This randomized, double-blinded, placebo-controlled clinical trial was carried out on 60 subjects, aged 18-40 years old. Subjects were randomly allocated to take either 50,000 IU vitamin D every 2 weeks plus 8 × 109 CFU/day probiotic (n = 30) or placebo (n = 30) for 12 weeks. RESULTS Vitamin D and probiotic co-supplementation, compared with the placebo, significantly improved beck depression inventory [β (difference in the mean of outcomes measures between treatment groups) - 0.58; 95% CI, - 1.15, - 0.02; P = 0.04], general health questionnaire scores (β - 0.93; 95% CI, - 1.78, - 0.08; P = 0.03) and depression, anxiety and stress scale scores (β - 0.90; 95% CI, - 1.67, - 0.13; P = 0.02). Vitamin D and probiotic co-supplementation was associated with a significant reduction in total testosterone (β - 0.19 ng/mL; 95% CI, - 0.28, - 0.10; P < 0.001), hirsutism (β - 0.95; 95% CI, - 1.39, - 0.51; P < 0.001), high-sensitivity C-reactive protein (hs-CRP) (β - 0.67 mg/L; 95% CI, - 0.97, - 0.38; P < 0.001) and malondialdehyde (MDA) levels (β - 0.25 μmol/L; 95% CI, - 0.40, - 0.10; P = 0.001), and a significant increase in total antioxidant capacity (TAC) (β 82.81 mmol/L; 95% CI, 42.86, 122.75; P < 0.001) and total glutathione (GSH) levels (β 40.42 μmol/L; 95% CI, 4.69, 76.19; P = 0.02), compared with the placebo. CONCLUSIONS Overall, the co-administration of vitamin D and probiotic for 12 weeks to women with PCOS had beneficial effects on mental health parameters, serum total testosterone, hirsutism, hs-CRP, plasma TAC, GSH and MDA levels. TRIAL REGISTRATION This study was retrospectively registered in the Iranian website ( www.irct.ir ) for registration of clinical trials ( IRCT20170513033941N37 ).
Methodological quality
Jadad score
:
4
Allocation concealment
:
Yes
