Table 2.
RCT evidence on the effects of vitamin D supplementation on clinical and metabolic parameters pertinent to PCOS.
| Study Design/Reference | Sample Size | Population | Intervention | Duration | Regimen | Study Parameters | Conclusions |
|---|---|---|---|---|---|---|---|
| Randomized, double blinded, placebo controlled trial Dastorani et al. [111] |
N = 40 (1:1 randomization) |
40 infertile PCOS patients who were IVF candidates PCOS diagnosis based on Rotterdam criteria Vitamin D deficiency not diagnosed at the beginning of the study |
Either vitamin D or placebo (paraffin capsules) | 8 weeks | 50,000 IU vitamin D or placebo every other week | AMH, insulin, HOMA-IR, insulin sensitivity check index (QUICKI), serum and total cholesterol | Compared to placebo, vitamin D supplementation resulted in significant lowering of serum AMH, insulin levels, HOMA-IR, serum total and LDL cholesterol level and improved QUICKI |
| Randomized, double blinded, placebo controlled trial Javed et al. [112] |
N = 40 (1:1 randomization) |
40 PCOS patients who were vitamin D deficient PCOS diagnosis based on the Rotterdam criteria |
Either vitamin D (n = 20) or placebo (n = 20) | 12 weeks | 3200 IU vitamin D or placebo daily | hs-CRP, lipid profile, insulin, HOMA-IR, glucose, Weight, BMI, FAI, Testosterone, SHBG, ALT, HA, PIIINP, TIMP-1, ELF score | Compared to placebo, vitamin D resulted in modest improvement in insulin sensitivity indices, significant reduction in ALT; there was no effect of vitamin D supplementation on CVD risk markers and hormones |
| Randomized, double blinded, placebo controlled trial Ostadmohammadi et al. [113] |
N = 60 (1:1 randomization) |
60 PCOS patients PCOS diagnosis based on Rotterdam criteria Vitamin D deficiency not diagnosed at the beginning of the study |
Vit D + probiotic vs. placebos (corn oil and starch) | 12 weeks | 50,000 IU vit D + 8 × 109 CFU/day probiotic or placebos every 2 weeks | Serum TT, hs-CRP, SHBG, NO, TAC, GSH, MDA, hirsutism (mFG scoring), mental health (BDI, GHQ-28, DASS), quality of sleep (PSQI) | Compared to placebo, vitamin D supplementation resulted in decrease in serum total testosterone level, improved hirsutism, lowering of hs-CRP, plasma TAC, GSH and MDA levels and had positive effects on mental health parameters compared to placebo. No significant effect was observed on SHBG, PSQI, plasma NO, acne and alopecia |
| Randomized, double blinded, placebo controlled trial Jamilian et al. [114] |
N = 60 (1:1 randomization) |
60 PCOS patients PCOS diagnosis based on Rotterdam criteria Vitamin D deficiency not diagnosed at the beginning of the study |
Vit D + omega 3FA vs. placebo | 12 weeks | 50,000 IU vitamin D every 2 weeks + 2000 mg omega 3 fatty acid/day OR placebo every 2 weeks | Total testosterone, SHBG, FAI, GSH, CRP, MDA, NO, TAC, IL-1, VEGF, hirsutism (mFG), depression and anxiety (BDI, DASS, GHQ-28) | Compared to placebo, vitamin D + omega 3 FA co-supplementation resulted in decrease in serum total cholesterol, hs-CRP, MDA, caused down regulation of IL-1, VEGF, increased TAC and showed improvement in BDI, DASS scores. No significant difference were observed in SHBG, FAI, plasma NO levels and GSH |
| Randomized, Double blinded, Placebo controlled trial Trummer et al. [115] |
N = 123 (2:1 randomization) |
123 Patients who were vitamin D insufficient PCOS diagnosis based on Rotterdam criteria Vitamin D insufficiency diagnosed as <75 nmol/L (<30 ng/mL) per the Endocrine society [47] |
Vitamin D (50 oily drops with cholecalciferol) (81) vs. placebo (similar oily drops without cholecalciferol) (41) | 24 weeks | 20,000 IU vitamin D3 weekly OR placebo weekly | AUC gluc during OGTT, HOMA-IR, total cholesterol, HbA1C, TT, FT, menstrual frequency, insulin sensitivity (QUICKI), TG | Compared to placebo, vitamin D resulted in decrease in plasma glucose during 60 min OGTT following 75 g glucose load ingestion at 12- and 24-week visit. No significant effect was observed on AUG gluc at end of 24 weeks and on other metabolic/endocrine parameters |
AMH: Anti-mullerian hormone; TT: Total testosterone; FT: Free testosterone; PIINP: N-terminal pro-peptide of type III pro-collagen; TIMP-1: Tissue inhibitor of metallo-prteinases-1; ELF: Enhanced liver fibrosis; HA: Hyaluronic acid; mF-G: Modified Ferriman-Gallewey scoring system; BDI: Beck depression inventory; GHQ-28: General health questionnaire-28; DASS: Depression anxiety and stress scale; PSQI: Pittsburgh sleep quality index; NO: Nitrous oxide; hs-CRP: high-sensitivity C-reactive protein; GSH: Total glutathione; TAC: Total anti-oxidant capacity; MDA: Malondialdehyde; AUG gluc: Plasma glucose area under curve; HOMA-IR: Homeostatic model assessment-insulin resistance; QUICKI: Quantitative insulin sensitivity check index; TG: Triglycerides.