Randomized Controlled Trial
Copyright ©The Author(s) 2025.
World J Diabetes. Aug 15, 2025; 16(8): 108166
Published online Aug 15, 2025. doi: 10.4239/wjd.v16.i8.108166
Table 1 The study population's baseline characteristics
Baseline characteristics
VD group (n = 60)
Control group (n = 60)
P value
Mean age/(years)65.4 ± 8.364.7 ± 7.9-
Sex distribution53.3% male, 46.7% female55.0% male, 45.0% female-
Duration of diabetes (years)12.1 ± 5.611.8 ± 5.2-
Ulcer size (cm²)5.6 ± 2.15.4 ± 2.30.62
Ulcer severityModerate to severeModerate to severe-
Baseline serum 25-(OH)D levels16.5 ± 4.8 ng/mL17.1 ± 5.0 ng/mL0.47
HbA1c (%)8.5 ± 1.28.6 ± 1.30.74
Other factors (BP, BMI)Comparable across both groupsComparable across both groups-
Table 2 Infection rates and severity in the vitamin D and control cohorts during 12-week intervention period
Infection outcome
VD group (n = 60)
Control group (n = 60)
P value
Absolute risk reduction
Infection incidence (%)25% (15/60)45% (27/60)0.0120%
Infection rate per 100 patient-days3.25.80.01
Relative risk reduction44%
95% confidence interval (infection incidence)18.0% to 32.0%36.0% to 54.0%
Severe infections requiring antibiotics (%)10% (6/60)25% (15/60)0.0315%
Hospitalization due to infection (%)5% (3/60)13% (8/60)8%
Table 3 The secondary outcomes: Wound healing, serum 25(OH)D levels, immune markers, and adverse events
Secondary outcome
VD group (n = 60)
Control group (n = 60)
P value
Wound healing
    Baseline ulcer size (cm²)5.65.4-
    Ulcer size at 6 weeks (cm²)3.6 (35% reduction from baseline)4.3 (20% reduction from baseline)-
    Ulcer size at 12 weeks (cm²)2.2 (60% reduction from baseline)3.5 (35% reduction from baseline)< 0.01
    Complete ulcer closure (%)20%10%-
Serum 25(OH)D levels (ng/mL)
    Baseline16.5 ± 4.817.1 ± 5.00.47
    Post-intervention (12 weeks)35.2 ± 7.518.3 ± 5.2< 0.001
Immune markers
    Cathelicidin (change from baseline)+30%No significant change< 0.01
    Pro-inflammatory cytokines (IL-6, TNF-α)-20%No significant change0.02
Adverse events
    Hypercalcemia0 cases0 cases-
    Other side effectsNone reportedNone reported-