Table 1.
n | Baseline | 12 months (12,000 IU) | 12 months (24,000 IU) | 12 months (48,000 IU) | ANCOVA b analysis |
---|---|---|---|---|---|
379 | 122 | 124 | 126 | ||
Age (years) | 74.1 [71.5–77.0] | 75.6 [72.5–77.3] | 76.0 [72.5–77.9] | 76.4 (4.4) | n/a |
Plasma calcium and renal function markers | |||||
Albumin (g/L) | 45.7 (2.2) | 44.6 (2.1)* | 44.5 (2.6)* | 44.3 (2.0)* | 0.70 |
Adjusted calcium (mmol/L) | 2.2 (0.1) | 2.3 (0.1) | 2.2 (0.1) | 2.2 (0.1) | 0.07 |
Phosphate (mmol/L) | 0.88 (0.18) | 0.79 (0.19)* | 0.81 (0.17)* | 0.81 (0.19)* | 0.68 |
Cystatin C (mg/L) | 0.87 (0.22) | 0.88 (0.27) | 0.92 (0.25)* | 0.95 (0.29)* | 0.41 |
Creatinine (μmol/L) | 82.1 (19.1) | 82.5 [67–94]* | 84.6 [71–96]* | 78.1 (66–88]* | 0.25 |
eGFR (mL/min per 1.73 m2) | 72 (15) | 73 (14) | 74 (16) | 70 (15) | 0.54 |
Klotho (pg/mL) | 493.7 [392.6–627.7] | 502.0 [403.1–639.6] | 502.7 [395.5–611.2] | 477.6 [399.6–589.2] | <0.001 |
cFGF23 (RU/mL) | 66.7 [54.9–84.2] | 90.8 [65.3–104.9]* | 85.7 [59.7–94.9]* | 77.8 [58.4–87.3]* | 0.11 |
iFGF23 (pg/mL) | 55.1 [44.5–72.7] | 66.9 [42.5–88.4]* | 71.7 [54.5–79.4]* | 73.2 [52.2–84.7]* | 0.80 |
iFGF23/cFGF23 | 1.9 [1.5–2.5] | 2.1 [1.4–2.2] | 2.2 [1.4–2.3] | 2.3 [1.4–2.3] | 0.75 |
Vitamin D metabolism markers | |||||
Total 25(OH)D (nmol/L) | 40.0 (20.1) | 55.9 (15.6)* | 64.6 (15.3)* | 79.0 (15.1)* | <0.001 |
Free 25(OH)D (pmol/L) | 8.4 (4.3) | 11.7 (3.3)* | 13.8 (3.4)* | 16.9 (4.3)* | <0.001 |
24,25(OH)2D (nmol/L) | 3.2 [2.0–5.5] | 6.1 (2.7)* | 7.4 (2.8)* | 9.4 (3.0)* | <0.001 |
25(OH)D/24,25(OH)2D | 14.5 [11.3–18.8] | 12.1 [9.4–12.9]* | 11.9 [10.0–13.4]* | 12.9 (4.7)* | <0.001 |
1,25(OH)2D (pmol/L) | 94.5 (29.0) | 100.6 (29.8) | 101.0 (29.4)* | 101.9 (30.8)* | 0.099 |
1,25(OH)2D/24,25(OH)2D | 25.7 [16.8–44.4] | 17.7 [11.9–21.8] | 14.6 [8.9–18.7] | 15.3 [9.0–18.2] | <0.001 |
DBP (mg/L) | 367.8 (63.4) | 362.5 (74.1) | 356.9 (46.1) | 384.4 (57.8)* | <0.01 |
PTH (pg/mL) | 43.4 [33.2–57.4] | 39.8 [28.8–53.5]* | 40.9 [26.3–55.5]* | 37.3 [27.8–47.5]* | <0.01 |
Wnt signaling pathway markers | |||||
SOST (pmol/L) | 44.3 [32.4–60.0] | 46.9 [32.6–63.5] | 45.4 [32.1–57.8] | 46.5 [33.2–61.2] | 0.20 |
DKK1 (pmol/L) | 31.2 (16.5) | 40.6 (17.9)* | 33.2 (19.0) | 38.9 (18.1)* | 0.87 |
OPG (pmol/L) | 5.67 (2.08) | 5.69 (2.04) | 5.12 [4.25–6.47] | 5.89 (2.17) | 0.20 |
sRANKL (pmol/L) | 0.12 [0.08–0.18] | 0.14 [0.08–0.18] | 0.13 [0.07–0.18] | 0.14 (0.07) | 0.75 |
sRANKL/OPG | 0.02 [0.01–0.04] | 0.03 [0.01–0.03] | 0.04 [0.01–0.04] | 0.03 [0.01–0.04] | 0.85 |
Bone mineral density and metabolism | |||||
Hip BMD (g/m2) | 0.98 (0.17) | 0.96 (0.15) | 0.98 (0.16) | 0.99 (0.18) | 0.19 |
Hip BMC (g) | 35.44 (8.30) | 34.08 (7.56) | 35.42 (7.92) | 35.73 (8.63) | 0.14 |
FN BMD (g/m2) | 0.902 (0.152) | 0.88 (0.13) | 0.90 (0.14) | 0.92 (0.15) | 0.13 |
FN BMC (g) | 4.90 (1.09) | 4.78 (0.96) | 4.82 (1.04) | 4.70 (1.16) | 0.72 |
BAP (μg/L) | 9.5 [7.9–12.3] | 11.4 [8.4–13.8]* | 10.7 [7.7–12.7] | 11.4 [8.0–14.1] | 0.87 |
CTX (ng/mL) | 0.40 [0.30–0.50] | 0.36 (0.16) | 0.37 (0.15) | 0.35 (0.14) | 0.48 |
PINP (μg/L) | 36.2 [28.8–46.2] | 40.1 [31.7–52.6] | 39.1 [31.0–46.6]* | 38.4 [28.9–47.1]* | 0.53 |
PINP/CTX | 101.4 [85.9–116.9] | 120.5 [103.6–155.2]* | 124.0 [107.6–158.5]* | 118.8 [100.8–157.1]* | 0.99 |
1,25(OH)2D = 1,25‐dihydroxy vitamin D; 24,25(OH)2D = 24,25‐dihydroxy vitamin D; 25(OH)D = 25‐hydroxy vitamin D; BAP = bone‐specific alkaline phosphatase; BMC = bone mineral content; BMD = bone mineral density; cFGF23 and iFGF23 = c‐terminal and intact fibroblast growth factor‐23, respectively; CTX = C‐terminal telopeptide; DBP = vitamin D binding protein; DKK1 = Dickkopf‐related protein 1; eGFR = estimated glomerular filtration rate; FN = femoral neck; OPG = osteoprotegerin; PINP = procollagen 1 intact N‐terminal; PTH = parathyroid hormone; SOST = sclerostin; sRANKL = soluble receptor activator of NF‐κB ligand.
For normally distributed data, results are expressed as mean (SD); skewed results are expressed as median [interquartile range].
ANCOVA was used to test between‐group differences after 12 months of supplementation, with the baseline value as a covariate.
*Denotes significantly different from baseline p < 0.05. Paired t tests were used to analyze pre‐ and post‐supplementation values for each supplementation group.