Table 2.

Twelve-month changes in serum IL1β, IL6, IL8, IL10,TNFα, BMI, adiponectin and leptin, and in the inflammatory biomarker score, by study arm

PlaceboVitamin D
Baseline (N = 109)12 mo (N = 94)ChangeBaseline (N = 109)12 mo (N = 93)ChangeAbsolute treatment effectdRelative treatment effecteP
VariableGeometric mean (95% CI)Geometric mean (95% CI)Absolute change (%)Geometric mean (95% CI)Geometric mean (95% CI)Absolute change (%)(95% CI)(95% CI)PaPb
BMI kg/m2 (ref. 29; SD)32.5 (6.1)29.7 (6.1)−2.8 (−8.8)32.3 (5.5)29.5 (5.6)−2.8 (−8.7)0.05 (−0.93–1.03)1.0 (0.97–1.03)0.630.82
IL1β (pg/mL)0.14 (0.10–0.22)0.12 (0.08–0.19)−0.02 (−15.9)0.11 (0.08–0.16)0.09 (0.06–0.15)−0.02 (−16.7)0 (−0.04–0.05)0.99 (0.7–1.4)0.280.12
IL6 (pg/mL)3.89 (3.15–4.79)3.52 (2.81–4.42)−0.36 (−9.3)3.89 (3.33–4.53)3.41 (2.82–4.12)−0.48 (−12.3)−0.12 (−0.92–0.69)0.97 (0.78–1.2)0.710.89
IL8 (pg/mL)6.38 (5.72–7.12)5.89 (5.12–6.78)−0.49 (−7.7)6.64 (5.66–7.80)6.30 (5.50–7.21)−0.34 (−5.2)0.15 (−0.92–1.13)1.03 (0.87–1.21)0.930.65
IL10 (pg/mL)16.46 (13.04–20.77)14.47 (10.87–19.26)−1.99 (−12.1)16.74 (13.43–20.87)15.02 (11.75–19.20)−1.72 (−10.3)0.27 (−4.42–4.66)1.02 (0.76–1.36)0.600.71
TNFα (pg/mL)9.35 (8.54–10.24)8.85 (7.94–9.85)−0.51 (−5.4)9.30 (8.45–10.24)9.14 (8.31–10.05)−0.16 (−1.8)0.34 (−0.81–1.50)1.04 (0.92–1.18)0.410.57
Inflammatory biomarker scorec1.05 (0.66–1.67)0.78 (0.47–1.31)−0.27 (−25.7)0.96 (0.61–1.51)0.76 (0.47–1.21)−0.21 (−21.5)0.06 (−0.45–0.57)1.06 (0.62–1.79)0.790.51
Adiponectin (μg/mL)11.04 (10.0–12.8)11.85 (10.71–13.1)0.81 (7.3)11.11 (10.19–12.14)12.12 (11.10–13.24)1.01 (9.1)0.2 (−0.68–1.07)1.02 (0.94–1.10)0.330.61
Leptin (ng/mL)36.17 (32.88–39.78)24.62 (21.27–28.49)−11.5 (−31.9)35.59 (32.27–39.24)23.5 (20.07–27.61)−12.0 (−33.9)0.50 (−4.51–3.45)0.97 (0.83–1.14)0.690.73
  • aP value was obtained from GEE model comparing 12-month change between vitamin D and placebo groups adjusted for baseline BMI.

  • bP value was obtained from GEE model adjusting for age, ethnicity, baseline serum 25(OH)D, baseline BMI, vitamin D intake (diet+supplement), calcium intake (diet+supplement), medication use, and average sun exposure.

  • cThe inflammatory biomarker score was calculated as described 33 using log-transformed IL1β, IL6, IL8, IL10, and TNFα.

  • dAbsolute treatment effect was calculated as (absolute change in vitamin D group − absolute change in Placebo group).

  • eRelative treatment effect was calculated as (follow-up geometric mean in vitamin D group) × (baseline geometric mean in Placebo group)/[(baseline geometric mean in vitamin D group) × (follow-up geometric mean in Placebo group)].