Table 4.
Main Characteristics of the Clinical Studies
| Author, Year | Study Design | Loca-tion | Samples Characteristics | Calciferol | Other Outcomes | ||||
|---|---|---|---|---|---|---|---|---|---|
| Included Sample | Sample Size | Obser-Vational Period | Vitamin D Derivate | Dose/Fre-Quency | Administra-tion Method | ||||
| Johansson, 202126 | RCT | Italy | Adults aged 75 years or younger with recently resected stage 2 cutaneous malignant melanoma | 104 | 3 years | Vitamin D3 | Oral solution in an ampoule of 100,000 IU vitamin D3 every 50 days (average of 2000 IU/day) | Oral | Serum levels of 25-OH-D rose sharply after 4 months of supplementation in the vitamin D arm (median of 33 ng/mL) compared to the placebo arm (median of 19 ng/mL), with persistent increase after 3 years of supplementation (42 ng/mL vs 22 ng/mL) |
| Passarelli, 202027 | RCT | USA | Adults who underwent polypecto-my for >1 colorectal adenoma within 120 days (secondary analysis) | 2259 | 11 years (median of 8.3 years) | Cholecalciferol (vitamin D3) | 1000 IU/day | Oral (Pill) | In basal cell carcinoma patients, lower incidence rate was observed in the vitamin D group compared to placebo (HR 0.96 [0.73–1.26]); and vitamin D+calcium compared to placebo (HR 0.99 [0.65–1.51]). Meanwhile in squamous cell carcinoma patients, vitamin D alone (HR 0.79 [0.49–1.27]) and vitamin D+calcium (HR 0.42 [0.19–0.91]) were a protective factor for non-melanoma skin cancer |
| Ince, 201928 | Pros-pective inter-ventio-nal study | Turkey | Patients who were admitted due to skin lesion and diagnosed with basal cell carcinoma; and then vitamin D3 intervention were used in BCC patients with 25-OH vitamin D3 level | 496 | Average of 32 months (24–36 months) | Cholecalciferol (vitamin D3) | 50,000 IU per week for 6 weeks | Oral (Pill) | The mean 25-OH vitamin D3 level in the recurrent BCC patients at the second stage was 10.1 ng/mL (range 4.1–23.8 ng/mL; male, 10.2 ng/mL vs female, 10.1 ng/mL). Recurrence was observed in 9.64% of the patients at the second stage (male, 10% vs female, 9.26%) |
| Rosenberg, 201929 | RCT | USA | Actinic keratosis patients who had completed previous trial | 130 | 3 Year | Calcipotriol + 5-FU | 0.005% topical ointment | Topical ointment | In the first year, the hazard ratio for keratinocyte cancer, basal cell carcinoma, and squamous cell carcinoma were 0.973 (0.261–3.625), 1.909 (0.319–11.427), 0.297 (0.033–2.654), respectively; In the second year the results were 0.741 (0.269–2.040), 1.673 (0.449–6.230), 0.335 (0.070–1.615), respectively; Meanwhile in the third year, the results were 0.575 (0.219–1.514), 1.709 (0.459–6.363), 0.215 (0.048–0.972), respectively. 5-FU+calcipotriol was effective in reducing the incidence of keratinocyte cancer and squamous cell carcinoma compared to that of BCC. |
| Brinkhuizen, 201630 | RCT | The Nether-lands | Patients with a primary, histological-ly proven superficial BCC and nodular BCC | 128 | 8 weeks | Combination of calcitriol with diclofenac | Calcitriol 3 ug/g; diclofenac 3% | Topical administration | sBCC treated with diclofenac showed a significant decrease in Ki-67 (p-value=0.001) and Bcl-2 (p-value=0.001), and a significant decrease in Ki-67 after combination therapy (p-value=0.012). Complete histological tumor regression was seen in 64.3% of sBCC patients receiving diclofenac (p-value=0.0003) and 43.8% of sBCC patients receiving combination therapy (p-value=0.007). On the other hand, no reduction was observed in the control group. Single calcitriol therapy did not induce tumor regression sufficiently |