This work is licensed under a Table 2.
Summary of clinical intervention studies investigating the effects of vitamin D treatment on clinical and biochemical parameters in PCOS women.
| Author | Study design | Subjects | Age | 25(OH)D levels (baseline) | Primary outcome | Study duration | Study medication | 25(OH)D levels (study end) | Effects on primary endpoints |
|---|---|---|---|---|---|---|---|---|---|
| Raza-Khan et al. (56) | RCT | 28 PCOS women | 28.2 ± 5.2 years (vitamin D group) vs 28.7 ± 5.6 years (placebo group) | 49.80 ± 23.64 nmol/L (vitamin D group) vs 55.41 ± 17.12 nmol/L (placebo group) | QUICKI | 12 weeks | 12,000 IU cholecalciferol daily vs placebo | 168.13 ± 71.44 nmol/L (vitamin D group) vs 56.04 ± 17.52 nmol/L (placebo group) | No significant effect |
| Irani et al. (58) | Uncontrolled intervention study | 22 PCOS women, 45 control women | 27.0 ± 0.9 years (PCOS vitamin D group) vs 31.3 ± 3.1 years (PCOS no intervention group) | 34.27 ± 2.40 nmol/L (PCOS intervention group) | sRAGE and AMH serum levels | 8 weeks | 50,000 IU 1,25 dihydroxyvitamin D3 weekly vs no intervention | 131.29 ± 21.39 nmol/L (PCOS intervention group) | Significant increase in sRAGE and decrease in AMH in the PCOS group |
| Asadi et al. (62) | RCT | 101 PCOS women | 26.29 ± 3.80 years vs 26.09 ± 3.46 years | 31.35 ± 2.72 nmol/L (vitamin D group) vs 30.53 ± 14.62 nmol/L (placebo group) | Endometrial thickness | 12 weeks | 300,000 IU cholecalciferol at study start vs placebo | Not available | Significantly higher endometrial thickness |
| Irani et al. (59) | RCT | 68 PCOS women | 30.5 ± 1.0 years (vitamin D group) vs 29.6 ± 1.7 years (placebo group) | 40.7 ± 2.2 nmol/L (vitamin D group) vs 42.4 ± 4.2 nmol/L (placebo group) | Serum TGF-β1, sENG, lipid profile, testosterone, DHEA-S, insulin resistance | 8 weeks | 50,000 IU cholecalciferol weekly vs placebo | 107.8 ± 6.0 nmol/L (vitamin D group) vs 43.4 ± 4.7 nmol/L (placebo group) | Significant decrease in time between menstrual periods, FG-score, triglycerides, TGF-β1 to sENG ratio |
| Garg et al. (57) | RCT | 36 PCOS women | 22.0 ± 4.61 years (vitamin D group) vs 22.8 ± 4.56 years (placebo group) | 19.22 ± 15.1 nmol/L (vitamin D group) vs 16.97 ± 6.14 nmol/L (placebo group) | Whole-body insulin sensitivity, Matsuda index, HOMA-IR, insulinogenic index | 6 months | 120,000 IU cholecalciferol monthly plus metformin 1500 mg daily vs placebo plus metformin 1500 mg daily | 78.62 ± 34.64 nmol/L (vitamin D group) vs 16.72 ± 5.77 nmol/L (placebo group) | No significant effect |
| Razavi et al. (61) | RCT | 60 PCOS women | Not shown | 35.9 ± 7.2 nmol/L (intervention group) vs 36.4 ± 13.7 nmol/L (placebo group) | Several endocrine biomarkers | 8 weeks | 200 IU of vitamin D, 90 µg of vitamin K2, 500 mg calcium twice daily vs placebo | 49.2 ± 7.7 nmol/L (intervention group) vs 36.2 ± 15.0 nmol/L (placebo group) | Significant decrease in free testosterone and DHEA-S |
| Significant increase in total antioxidant capacity and plasma malondialdehyde | |||||||||
| Maktabi et al. (55) | RCT | 70 PCOS women | 22.0 ± 1.6 years (vitamin D group) vs 23.1 ± 3.3 years (placebo group) | 31.9 ± 11.2 nmol/L (vitamin D group) vs 36.2 ± 12.7 nmol/L (placebo group) | Markers of insulin resistance and androgens | 12 weeks | 50,000 IU cholecalciferol every 2 weeks vs placebo | 68.6 ± 24.5 nmol/L (vitamin D group) vs 35.9 ± 13.0 nmol/L (placebo group) | Significant decrease in FPG, insulin, HOMA-IR, HOMA-B, hs-CRP, plasma malondialdehyde |
| Significant increase in QUICKI (non-significant after adjustment) | |||||||||
| Irani et al. (60) | RCT | 68 PCOS women | 30.5 ± 1.0 years (vitamin D group) vs 29.6 ± 1.7 years (placebo group) | 40.7 ± 2.2 nmol/L (vitamin D group) vs 42.4 ± 4.5 nmol/L (placebo group) | VEGF | 8 weeks | 50,000 IU cholecalciferol weekly vs placebo | 107.8 ± 6.0 nmol/L (vitamin D group) vs 43.4 ± 4.7 nmol/L (placebo group) | Significant decrease in VEGF concentrations |
| Foroozanfard et al. (54) | RCT | 90 PCOS women | Not shown | 33.7 ± 7.7 nmol/L (4000 IU group) vs 34.9 ± 11.5 nmol/L (1000 IU group) vs 34.9 ± 8.7 nmol/L (placebo group) | Various hormonal parameters | 12 weeks | 4000 IU cholecalciferol vs 1000 IU cholecalciferol vs placebo | 60.7 ± 9.2 nmol/L (4000 IU group) vs 51.7 ± 15.5 nmol/L (1000 IU group) vs 35.2 ± 9.0 nmol/L (placebo group) | Significant decrease in FPG, serum insulin, HOMA-IR, triglycerides, VLDL, total cholesterol, LDL-cholesterol, total cholesterol/HDL-cholesterol ratio |
| Jamilian et al. (53) | RCT | 90 PCOS women | 28 ± 5 years (4000 IU group) vs 26 ± 5 years (1000 IU group) vs 25 ± 5 years (placebo group) | 31.4 ± 6.7 nmol/L (4000 IU group) vs 31.4 ± 8.5 nmol/L (1000 IU group) vs 32.2 ± 6.0 nmol/L (placebo group) | Various hormonal parameters | 12 weeks | 4000 IU cholecalciferol daily vs 1000 IU cholecalciferol daily vs placebo | 61.4 ± 8.2 nmol/L (4000 IU group) vs 46.2 ± 12.2 nmol/L (1000 IU group) vs 32.7 ± 6.2 nmol/L (placebo group) | Significant decrease in FPG, serum insulin, HOMA-IR, TT, FAI, and hirsutism |
| Significant increase in SHBG and total antioxidant capacity |
Data are given as mean ± s.d. or median (IQR) unless otherwise stated.
25(OH)D, 25-hydroxyvitamin D; AMH, antimüllerian hormone; BMI, body mass index; DHEA-S, dehydroepiandrosterone-sulfate; FAI, free androgen index; FG-score, Ferriman-Gallwey-score; FPG, fasting plasma glucose; FSH, follicle-stimulating hormone; HDL-cholesterol, high density lipoprotein-cholesterol; HOMA-B, homeostasis model assessment-estimated beta cell function; HOMA-IR, homeostasis model assessment-insulin resistance; hs-CRP, high-sensitive C-reactive protein; IR, insulin resistance; IU, international units; LDL cholesterol, low-density lipoprotein-cholesterol; LH, luteinizing hormone; OR, odds ratio; PCOS, polycystic ovary syndrome; QUICKI, quantitative insulin sensitivity check index; RCT, randomized controlled trial; sENG, soluble endoglin; SHBG, sex hormone-binding globulin; sRAGE, soluble receptor for advanced glycation end products; TGF-β1, transforming growth factor-β1; TT, total testosterone; VEGF, vascular endothelial growth factor; VLDL, very low density lipoprotein.