Table 3.

Twelve-month changes in serum IL1β, IL6, IL8, IL10, TNFα, an Inflammatory Biomarker Score, and adiponectin and leptin, by study arm, stratified by percent weight loss

PlaceboVitamin D
Baseline (N = 94)12 mo (N = 94)Baseline (N = 94)12 mo (N = 93)Absolute treatment effectcRelative treatment effectd
Weight lossGeometric mean (95% CI)Geometric mean (95% CI)Absolute change (%)Geometric mean (95% CI)Geometric mean (95% CI)Absolute change (%)(95% CI)(95% CI)PaPb
IL1β (pg/mL)
 No change/gained weight0.11 (0.03–0.51)0.07 (0.03–0.18)−0.04 (−35.9)0.10 (0.03–0.27)0.19 (0.06–0.60)0.10 (102.5)0.14 (0.01–0.52)3.16 (1.06–11.23)Ref.Ref.
 Lost <5% baseline weight0.16 (0.06–0.43)0.13 (0.05–0.35)−0.03 (−17.9)0.18 (0.07–0.45)0.17 (0.08–0.40)−0.01 (−1.6)0.02 (−0.09–0.13)1.2 (0.73–2.01)0.150.03
 Lost 5%–10% baseline weight0.16 (0.07–0.36)0.10 (0.04–0.27)−0.06 (−36.4)0.08 (0.04–0.16)0.05 (0.02–0.13)−0.02 (−27.7)0.04 (−0.02–0.12)1.14 (0.67–1.98)0.130.02
 Lost ≥10% baseline weight0.15 (0.07–0.30)0.15 (0.08–0.29)0.00e (1.6)0.08 (0.04–0.17)0.08 (0.04–0.17)−0.01 (−6.0)−0.01 (−0.07–0.93)0.93 (0.57–1.49)0.060.008
IL6 (pg/mL)
 No change/gained weight6.17 (2.53–15.05)4.30 (2.13–8.70)−1.87 (−30.3)3.76 (2.52–5.62)4.59 (2.88–7.33)0.83 (22.2)2.7 (0.03–8.64)1.75 (1.00–3.19)Ref.Ref.
 Lost <5% baseline weight4.43 (2.88–6.82)4.51 (3.14–6.48)0.08 (1.9)3.65 (2.60–5.14)3.80 (2.66–5.42)0.14 (3.9)0.06 (−1.43–1.79)1.02 (0.70–1.49)0.120.03
 Lost 5%–10% baseline weight4.37 (3.12–6.12)3.62 (2.25–5.81)−0.75 (−17.2)4.76 (3.58–6.32)2.98 (1.97–4.52)−1.77 (−37.3)−1.02 (−2.91–0.54)0.76 (0.48–1.15)0.020.004
 Lost ≥10% baseline weight2.99 (2.10–4.24)2.58 (1.74–3.83)−0.41 (−13.6)3.89 (2.85–5.30)3.22 (2.39–4.33)−0.67 (−17.3)−0.27 (−1.28–0.65)0.96 (0.71–1.30)0.070.02
IL8 (pg/mL)
 No change/gained weight6.26 (4.05–9.66)5.56 (3.63–8.53)−0.70 (−11.1)6.90 (5.35–8.88)6.54 (5.16–8.30)−0.35 (−5.1)0.34 (−1.82–2.70)1.07 (0.77–1.51)Ref.Ref.
 Lost <5% baseline weight7.62 (6.38–9.09)7.43 (6.03–9.15)−0.19 (−2.5)8.62 (5.45–13.62)7.36 (5.74–9.42)−1.26 (−14.6)−1.07 (−5.82–1.35)0.88 (0.58–1.20)0.330.53
 Lost 5%–10% baseline weight7.19 (5.85–8.84)5.74 (4.31–7.63)−1.45 (−20.2)6.72 (5.31–8.50)5.57 (4.24–7.32)−1.15 (−17.1)0.31 (−1.39–1.95)1.04 (0.79–1.38)0.900.56
 Lost ≥10% baseline weight5.45 (4.48–6.63)5.02 (3.86–6.52)−0.43 (−7.9)6.75 (4.77–9.56)6.30 (4.91–8.08)−0.45 (−6.7)−0.02 (−1.92–1.46)1.01 (0.78–1.34)0.780.83
IL10 (pg/mL)
 No change/gained weight12.68 (6.41–25.05)9.51 (3.25–27.81)−3.16 (−25.0)26.03 (15.89–42.63)27.82 (18.29–42.30)1.79 (6.9)4.95 (−8.31–15.68)1.42 (0.79–2.78)Ref.Ref.
 Lost <5% baseline weight19.88 (13.47–29.33)14.27 (8.29–24.54)−5.61 (−28.2)12.55 (7.37–21.36)12.77 (7.00–23.28)0.22 (1.7)5.83 (−2.27–14.73)1.42 (0.80–2.64)0.800.79
 Lost 5%–10% baseline weight14.04 (9.23–21.37)12.28 (6.51–23.15)−1.77 (−12.6)18.27 (10.37–32.18)12.72 (8.02–20.18)−5.55 (−30.4)−3.78 (−16.9–2.52)0.80 (0.44–1.29)0.180.09
 Lost ≥10% baseline weight20.24 (13.33–30.73)19.46 (13.64–27.76)−0.78 (−3.9)17.87 (13.10–24.36)15.18 (10.11–22.80)−2.68 (−15.0)−1.9 (−7.53–4.56)0.88 (0.62–1.24)0.130.06
TNFα
 No change/gained weight8.18 (6.16–10.87)7.94 (6.01–10.50)−0.24 (−2.9)7.66 (5.60–10.48)8.44 (6.15–11.58)0.78 (10.2)1.01 (−1.6–4.06)1.13 (0.82–1.64)Ref.Ref.
 Lost <5% baseline weight10.32 (8.65–12.32)10.53 (8.96–12.38)0.21 (2.1)10.56 (8.83–12.62)11.55 (10.10–13.21)1.00 (9.4)0.78 (−0.9–2.46)1.07 (0.92–1.26)0.850.33
 Lost 5%–10% baseline weight9.69 (8.30–11.31)7.75 (6.11–9.83)−1.94 (−20.1)9.41 (7.66–11.54)8.74 (7.23–10.58)−0.66 (−7.0)1.28 (−1.16–3.87)1.16 (0.88–1.6)0.760.57
 Lost ≥10% baseline weight9.68 (8.17–11.47)8.74 (7.17–10.66)−0.94 (−9.7)9.60 (8.23–11.19)8.53 (7.33–9.92)−1.07 (−11.1)−0.13 (−1.76–1.41)0.98 (0.83–1.17)0.560.12
Inflammatory Biomarker Score
 No change/gained weight1.410.80−0.61 (−43.2)0.430.790.36 (84.1)0.97 (−0.25–6.26)3.24 (0.71–17.43)Ref.Ref.
 Lost <5% baseline weight1.702.090.39 (−23.1)2.622.58−0.05 (−1.8)−0.44 (−5.84–1.54)0.8 (0.31–1.97)0.160.05
 Lost 5%–10% baseline weight1.810.63−1.18 (−65.2)0.950.45−0.49 (−52.1)0.69 (−0.51–2.91)1.38 (0.48–4.47)0.450.09
 Lost ≥10% baseline weight0.590.39−0.21 (−34.7)0.870.57−0.30 (−34.3)−0.09 (−0.99–0.47)1.01 (0.48–2.06)0.260.06
Adiponectin (μg/mL)
 No change/gained weight13.35 (10.61–16.80)13.06 (10.45–16.33)−0.29 (−2.2)11.37 (9.24–13.97)10.78 (8.79–13.23)−0.58 (−5.1)−0.29 (−1.27–0.69)0.97 (0.90–1.04)Ref.Ref.
 Lost <5% baseline weight11.61 (9.37–14.39)11.56 (9.46–14.14)−0.05 (−0.4)12.29 (9.73–15.52)12.62 (10.17–15.65)0.33 (2.7)0.38 (−0.73–1.42)1.03 (0.94–1.12)0.180.38
 Lost 5%–10% baseline weight10.47 (8.68–12.63)11.34 (9.47–13.59)0.88 (8.4)10.84 (9.37–12.54)11.22 (9.71–12.97)0.39 (3.6)−0.49 (−1.67–0.60)0.96 (0.86–1.06)0.590.36
 Lost ≥10% baseline weight10.29 (8.63–12.26)12.04 (9.94–14.58)1.75 (17)10.57 (8.84–12.65)13.18 (11.31–15.37)2.61 (24.7)0.85 (−0.45–2.15)1.07 (0.96–1.19)0.090.19
Leptin (ng/mL)
 No change/gained weight46.16 (35.16–60.61)46.27 (36.34–58.93)0.11 (0.2)38.84 (29.00–52.01)44.24 (31.92–61.31)5.40 (13.9)5.29 (−2.27–14.19)1.14 (0.95–1.35)Ref.Ref.
 Lost <5% baseline weight34.15 (27.24–42.82)31.24 (25.77–37.89)−2.91 (−8.5)29.67 (23.41–37.61)29.61 (23.88–36.73)−0.05 (−0.2)2.86 (−2.39–8.31)1.09 (0.92–1.30)0.600.98
 Lost 5%–10% baseline weight34.33 (27.99–42.12)25.34 (19.46–33.00)−9.00 (−26.2)35.77 (29.24–43.75)26.24 (20.29–33.94)−9.53 (−26.6)−0.53 (−4.15–3.05)0.99 (0.86–1.14)0.150.25
 Lost ≥10% baseline weight34.32 (29.56–39.84)15.22 (11.72–19.77)−19.1 (−55.7)36.18 (30.25–43.27)14.85 (11.18–19.72)−21.3 (−59.0)−2.23 (−7.81–2.82)0.93 (0.72–1.19)0.130.22
  • aGEE model, P value comparing differences between vitamin D and Placebo arms, within each weight strata, compared with those participants who had no change/gained weight after 12 months (referent), adjusted for baseline BMI.

  • bGEE model, P value comparing differences between vitamin D and Placebo arms within each weight strata, compared with those participants who had no change/gained weight after 12 months (referent)., adjusting for age, race/ethnicity, baseline serum 25(OH)D, vitamin D intake (diet+supplement), calcium intake (diet+supplement), medication use, and average sun exposure.

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

  • dRelative 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)].

  • eAbsolute changes appear as 0.00 due to rounding.