Table 1 Characteristics of included trials.
Name (country, year) | Rx duration | Total/CRC casesa | Participant population | Intervention | Comparator | Primary outcome | Relevant secondary outcome | Follow-up from Rx start | CRC deaths | Overall survival | CRC-specific survival | Progression-free survival |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
CRC/adenoma trials | ||||||||||||
Golubic et al.31 (Croatia, 2018) | 2 years | 71/71 | Metastatic CRC, age 24–79 years | 2000 IU/day vitamin D3 + standard chemotherapy | No placebo | OS | PFS | 46 months | Not known | HR = 1.01 (95% CI 0.39–2.61) | NA | HR = 1.11 (95% CI 0.69–1.77) |
SUNSHINE32 (USA, 2019) | 23 months | 139/139 | Metastatic CRC | 4000 IU/day vitamin D3 + standard chemotherapy | 400 IU/day vitamin D3 | PFS | OS | 23 months | 111 | 24.3 vs. 24.3 months; P = 0.43 | NA | HR = 0.64 (95% CI 0–0.90) |
AMATERASU33 (Japan, 2019) | 3.5 years | 201/201 | Epithelial carcinoma of digestive tract (stages 1–3) | 2000 IU/day vitamin D3 + standard chemotherapy | Placebo | PFS | OS | 3.5 years | Not known | HR = 0.95 (95% CI 0.57–1.57) | NA | HR = 0.69 (95% CI 0.39–1.24) |
Population trials | ||||||||||||
Trivedi et al.34 (UK, 2003) | 5 years | 2686/55 | Aged 65–85 years | 100,000 IU/4m vitamin D3 | Placebo | Fracture incidence, mortality | Colon-DSS | NA | 18 | NA | HR = 0.62 (95% CI 0.24–1.60) | NA |
WHI trial7 (USA, 2006) | 7 years | 36,282/322 | Post-menopausal women, 50–79 years | 400 IU/day vitamin D3 + CaCO3 | Placebo | Hip fracture | CRC risk | 7 years | 75 | HR = 0.91 (95% CI 0.83–1.01); (total trial mortality) | HR0.82 (95% CI 0.52–1.29) | NA |
RECORD trial39 (UK, 2012) | 24–62 months | 5292/71 | Aged >70 years, fracture | 800 IU/day vitamin D3 ± calcium | Placebo ± calcium | Fracture | OS, PFS | 24–62 months | 33 | HR = 0.80 (95% CI 0.61–1.11) (total trial mortality) | 20/41 deaths (vitamin D3) vs.13/30; P = 0.83† | NA |
VITAL trial35 (USA, 2019) | 5 years | 25,871/98 | Men ≥50 years, women ≥55 years | 2000 IU/day vitamin D3 + omega-3 fatty acids | Placebo | Invasive cancer risk | Cancer mortality | 5.3 years | 25 | NA | HR = 0.65 (95% CI 0.28–1.50) | HR = 0.79 (95% CI 0.36–1.75) |
