Table 3
Open in new tab

Serum concentrations of 25(OH)D3, adjusted calcium, PTH, and bone turnover markers at 3-yr follow-up by allocation: bone sub-study, overall, and by sub-group.

Vitamin D arm: mean value (SD) [N]Placebo arm: mean value (SD) [N]Adjusted mean difference (95% CI)aPP for interaction
25(OH)D3, nmol/L
Overall97.6 (21.5) [202]58.8 (14.2) [187]39.9 (36.1 to 43.6)<.001—
By sexMale99.8 (22.9) [97]62.7 (13.5) [88]39.7 (33.9 to 45.4)<.001.89
Female95.6 (20.0) [105]55.3 (14.1) [99]40.1 (35.5 to 44.7)<.001
By baseline 25(OH)D3 concentrationb<75 nmol/L98.8 (20.6) [94]57.9 (14.4) [95]43.3 (38.2 to 48.3)<.001.04
≥75 nmol/L95.7 (20.5) [102]59. 8 (14.2) [89]35.6 (30.4 to 40.7)<.001
By calcium intake<Medianc92.4 (19.3) [103]53.7 (13.8) [94]37.7 (33.2 to 42.2)<.001.11
≥Medianc107.9 (22.8) [60]65.0 (12.3) [54]44.3 (37.7 to 50.9)<.001
Adjusted calcium, mmol/L
Overall2.28 (0.07) [201]2.27 (0.07) [186]0.01 (0.00 to 0.03).06
By sexMale2.28 (0.07) [97]2.27 (0.07) [88]0.02 (0.00 to 0.04).12.59
Female2.27 (0.07) [104]2.27 (0.06) [98]0.01 (−0.01 to 0.03).32
By baseline 25(OH)D3 concentrationb<75 nmol/L2.28 (0.07) [94]2.27 (0.07) [95]0.01 (−0.01 to 0.03).34.70
≥75 nmol/L2.27 (0.07) [101]2.27 (0.06) [88]0.02 (0.00 to 0.04).08
By calcium intake<Medianc2.28 (0.07) [103]2.27 (0.07) [94]0.01 (−0.01 to 0.03).22.64
≥Medianc2.29 (0.08) [59]2.27 (0.06) [54]0.02 (−0.01 to 0.04).12
PTH, pmol/L
Overall4.18 (1.77) [201]4.51 (1.86) [186]−0.55 (−0.94 to −0.17).005
By sexMale4.14 (1.75) [97]4.20 (1.74) [88]−0.22 (−0.76 to 0.32).43.10
Female4.23 (1.80) [104]4.78 (1.92) [98]−0.83 (−1.38 to −0.29).003
By baseline 25(OH)D3 concentrationb<75 nmol/L4.43 (1.79) [103]4.92 (1.96) [94]−0.57 (−1.07 to −0.06).03.73
≥75 nmol/L3.93 (1.95) [59]4.21 (1.63) [54]−0.52 (−1.08 to 0.04).07
By calcium intake<Medianc4.22 (1.84) [94]4.38 (1.80) [95]−0.48 (−1.05 to 0.09).10.74
≥Medianc4.17 (1.72) [101]4.63 (1.95) [88]−0.58 (−1.13 to −0.04).04
Total ALP, IU/L
Overall303.5 (111.6) [202]302.5 (116.9) [186]−5.2 (−30.8 to 20.5).69
By sexMale361.9 (93.4) [97]349.2 (120.4) [88]0.4 (−30.7 to 31.6).98.37
Female249.5 (99.6) [105]260.6 (96.5) [98]−17.4 (−46.0 to 11.3).23
By baseline 25(OH)D3 concentrationb<75 nmol/L284.1 (107.6) [103]305.1 (132.6) [94]−19.2 (−52.5 to 14.2).26.18
≥75 nmol/L323.3 (117.0) [60]300.7 (99.5) [54]10.3 (−26.9 to 47.5).59
By calcium intake<Medianc328.5 (116.4) [94]295.4 (103.2) [95]27.2 (−7.9 to 62.3).13.02
≥Medianc280.5 (103.9) [102]310.0 (131.2) [88]−32.4 (−70.2 to 5.5).09
CTX, μg/L
Overall1.30 (0.72) [201]1.21 (0.49) [186]0.07 (−0.07 to 0.21).31
By sexMale1.62 (0.80) [97]1.39 (0.43) [88]0.19 (0.00 to 0.38).048.03
Female0.99 (0.48) [104]1.05 (0.48) [98]−0.09 (−0.23 to 0.06).23
By baseline 25(OH)D3 concentrationb<75 nmol/L1.24 (0.70) [103]1.18 (0.50) [94]0.07 (−0.09 to 0.24).39.98
≥75 nmol/L1.34 (0.77) [59]1.28 (0.52) [54]0.06 (−0.18 to 0.30).61
By calcium intake<Medianc1.37 (0.77) [94]1.27 (0.45) [95]0.04 (−0.15 to 0.23)..69.53
≥Medianc1.22 (0.69) [101]1.14 (0.52) [88]0.11 (−0.08 to 0.31).26
P1NP, μg/L
Overall726.5 (408.7) [201]692.8 (334.9) [186]46.2 (−38.2 to 130.5).28
By sexBoys928.8 (418.8) [97]816.5 (315.1) [88]106.6 (−8.8 to 222.1).07.049
Girls537.9 (294.1) [104]581.8 (313.8) [98]−19.1 (−104.3 to 66.1).66
By baseline 25(OH)D3 concentrationb<75 nmol/L665.3 (362.8) [103]658.3 (361.5) [94]10.7 (−89.1 to 110.6).83.26
≥75 nmol/L795.6 (472.4) [59]690.4 (309.9) [54]101.2 (−46.0 to 248.4).18
By calcium intake<Medianc800.2 (447.6) [94]699.0 (307.6) [95]109.8 (−17.1 to 236.6).09.16
≥Medianc659.2 (365.8) [101]678.6 (362.3) [88]−4.7 (−116.7 to 107.3).93
Vitamin D arm: mean value (SD) [N]Placebo arm: mean value (SD) [N]Adjusted mean difference (95% CI)aPP for interaction
25(OH)D3, nmol/L
Overall97.6 (21.5) [202]58.8 (14.2) [187]39.9 (36.1 to 43.6)<.001—
By sexMale99.8 (22.9) [97]62.7 (13.5) [88]39.7 (33.9 to 45.4)<.001.89
Female95.6 (20.0) [105]55.3 (14.1) [99]40.1 (35.5 to 44.7)<.001
By baseline 25(OH)D3 concentrationb<75 nmol/L98.8 (20.6) [94]57.9 (14.4) [95]43.3 (38.2 to 48.3)<.001.04
≥75 nmol/L95.7 (20.5) [102]59. 8 (14.2) [89]35.6 (30.4 to 40.7)<.001
By calcium intake<Medianc92.4 (19.3) [103]53.7 (13.8) [94]37.7 (33.2 to 42.2)<.001.11
≥Medianc107.9 (22.8) [60]65.0 (12.3) [54]44.3 (37.7 to 50.9)<.001
Adjusted calcium, mmol/L
Overall2.28 (0.07) [201]2.27 (0.07) [186]0.01 (0.00 to 0.03).06
By sexMale2.28 (0.07) [97]2.27 (0.07) [88]0.02 (0.00 to 0.04).12.59
Female2.27 (0.07) [104]2.27 (0.06) [98]0.01 (−0.01 to 0.03).32
By baseline 25(OH)D3 concentrationb<75 nmol/L2.28 (0.07) [94]2.27 (0.07) [95]0.01 (−0.01 to 0.03).34.70
≥75 nmol/L2.27 (0.07) [101]2.27 (0.06) [88]0.02 (0.00 to 0.04).08
By calcium intake<Medianc2.28 (0.07) [103]2.27 (0.07) [94]0.01 (−0.01 to 0.03).22.64
≥Medianc2.29 (0.08) [59]2.27 (0.06) [54]0.02 (−0.01 to 0.04).12
PTH, pmol/L
Overall4.18 (1.77) [201]4.51 (1.86) [186]−0.55 (−0.94 to −0.17).005
By sexMale4.14 (1.75) [97]4.20 (1.74) [88]−0.22 (−0.76 to 0.32).43.10
Female4.23 (1.80) [104]4.78 (1.92) [98]−0.83 (−1.38 to −0.29).003
By baseline 25(OH)D3 concentrationb<75 nmol/L4.43 (1.79) [103]4.92 (1.96) [94]−0.57 (−1.07 to −0.06).03.73
≥75 nmol/L3.93 (1.95) [59]4.21 (1.63) [54]−0.52 (−1.08 to 0.04).07
By calcium intake<Medianc4.22 (1.84) [94]4.38 (1.80) [95]−0.48 (−1.05 to 0.09).10.74
≥Medianc4.17 (1.72) [101]4.63 (1.95) [88]−0.58 (−1.13 to −0.04).04
Total ALP, IU/L
Overall303.5 (111.6) [202]302.5 (116.9) [186]−5.2 (−30.8 to 20.5).69
By sexMale361.9 (93.4) [97]349.2 (120.4) [88]0.4 (−30.7 to 31.6).98.37
Female249.5 (99.6) [105]260.6 (96.5) [98]−17.4 (−46.0 to 11.3).23
By baseline 25(OH)D3 concentrationb<75 nmol/L284.1 (107.6) [103]305.1 (132.6) [94]−19.2 (−52.5 to 14.2).26.18
≥75 nmol/L323.3 (117.0) [60]300.7 (99.5) [54]10.3 (−26.9 to 47.5).59
By calcium intake<Medianc328.5 (116.4) [94]295.4 (103.2) [95]27.2 (−7.9 to 62.3).13.02
≥Medianc280.5 (103.9) [102]310.0 (131.2) [88]−32.4 (−70.2 to 5.5).09
CTX, μg/L
Overall1.30 (0.72) [201]1.21 (0.49) [186]0.07 (−0.07 to 0.21).31
By sexMale1.62 (0.80) [97]1.39 (0.43) [88]0.19 (0.00 to 0.38).048.03
Female0.99 (0.48) [104]1.05 (0.48) [98]−0.09 (−0.23 to 0.06).23
By baseline 25(OH)D3 concentrationb<75 nmol/L1.24 (0.70) [103]1.18 (0.50) [94]0.07 (−0.09 to 0.24).39.98
≥75 nmol/L1.34 (0.77) [59]1.28 (0.52) [54]0.06 (−0.18 to 0.30).61
By calcium intake<Medianc1.37 (0.77) [94]1.27 (0.45) [95]0.04 (−0.15 to 0.23)..69.53
≥Medianc1.22 (0.69) [101]1.14 (0.52) [88]0.11 (−0.08 to 0.31).26
P1NP, μg/L
Overall726.5 (408.7) [201]692.8 (334.9) [186]46.2 (−38.2 to 130.5).28
By sexBoys928.8 (418.8) [97]816.5 (315.1) [88]106.6 (−8.8 to 222.1).07.049
Girls537.9 (294.1) [104]581.8 (313.8) [98]−19.1 (−104.3 to 66.1).66
By baseline 25(OH)D3 concentrationb<75 nmol/L665.3 (362.8) [103]658.3 (361.5) [94]10.7 (−89.1 to 110.6).83.26
≥75 nmol/L795.6 (472.4) [59]690.4 (309.9) [54]101.2 (−46.0 to 248.4).18
By calcium intake<Medianc800.2 (447.6) [94]699.0 (307.6) [95]109.8 (−17.1 to 236.6).09.16
≥Medianc659.2 (365.8) [101]678.6 (362.3) [88]−4.7 (−116.7 to 107.3).93

N, number.

a

Adjusted for baseline value and school of attendance.

bDeseasonalized values.

cMedian calcium intake 466 mg/d.

Table 3
Open in new tab

Serum concentrations of 25(OH)D3, adjusted calcium, PTH, and bone turnover markers at 3-yr follow-up by allocation: bone sub-study, overall, and by sub-group.

Vitamin D arm: mean value (SD) [N]Placebo arm: mean value (SD) [N]Adjusted mean difference (95% CI)aPP for interaction
25(OH)D3, nmol/L
Overall97.6 (21.5) [202]58.8 (14.2) [187]39.9 (36.1 to 43.6)<.001—
By sexMale99.8 (22.9) [97]62.7 (13.5) [88]39.7 (33.9 to 45.4)<.001.89
Female95.6 (20.0) [105]55.3 (14.1) [99]40.1 (35.5 to 44.7)<.001
By baseline 25(OH)D3 concentrationb<75 nmol/L98.8 (20.6) [94]57.9 (14.4) [95]43.3 (38.2 to 48.3)<.001.04
≥75 nmol/L95.7 (20.5) [102]59. 8 (14.2) [89]35.6 (30.4 to 40.7)<.001
By calcium intake<Medianc92.4 (19.3) [103]53.7 (13.8) [94]37.7 (33.2 to 42.2)<.001.11
≥Medianc107.9 (22.8) [60]65.0 (12.3) [54]44.3 (37.7 to 50.9)<.001
Adjusted calcium, mmol/L
Overall2.28 (0.07) [201]2.27 (0.07) [186]0.01 (0.00 to 0.03).06
By sexMale2.28 (0.07) [97]2.27 (0.07) [88]0.02 (0.00 to 0.04).12.59
Female2.27 (0.07) [104]2.27 (0.06) [98]0.01 (−0.01 to 0.03).32
By baseline 25(OH)D3 concentrationb<75 nmol/L2.28 (0.07) [94]2.27 (0.07) [95]0.01 (−0.01 to 0.03).34.70
≥75 nmol/L2.27 (0.07) [101]2.27 (0.06) [88]0.02 (0.00 to 0.04).08
By calcium intake<Medianc2.28 (0.07) [103]2.27 (0.07) [94]0.01 (−0.01 to 0.03).22.64
≥Medianc2.29 (0.08) [59]2.27 (0.06) [54]0.02 (−0.01 to 0.04).12
PTH, pmol/L
Overall4.18 (1.77) [201]4.51 (1.86) [186]−0.55 (−0.94 to −0.17).005
By sexMale4.14 (1.75) [97]4.20 (1.74) [88]−0.22 (−0.76 to 0.32).43.10
Female4.23 (1.80) [104]4.78 (1.92) [98]−0.83 (−1.38 to −0.29).003
By baseline 25(OH)D3 concentrationb<75 nmol/L4.43 (1.79) [103]4.92 (1.96) [94]−0.57 (−1.07 to −0.06).03.73
≥75 nmol/L3.93 (1.95) [59]4.21 (1.63) [54]−0.52 (−1.08 to 0.04).07
By calcium intake<Medianc4.22 (1.84) [94]4.38 (1.80) [95]−0.48 (−1.05 to 0.09).10.74
≥Medianc4.17 (1.72) [101]4.63 (1.95) [88]−0.58 (−1.13 to −0.04).04
Total ALP, IU/L
Overall303.5 (111.6) [202]302.5 (116.9) [186]−5.2 (−30.8 to 20.5).69
By sexMale361.9 (93.4) [97]349.2 (120.4) [88]0.4 (−30.7 to 31.6).98.37
Female249.5 (99.6) [105]260.6 (96.5) [98]−17.4 (−46.0 to 11.3).23
By baseline 25(OH)D3 concentrationb<75 nmol/L284.1 (107.6) [103]305.1 (132.6) [94]−19.2 (−52.5 to 14.2).26.18
≥75 nmol/L323.3 (117.0) [60]300.7 (99.5) [54]10.3 (−26.9 to 47.5).59
By calcium intake<Medianc328.5 (116.4) [94]295.4 (103.2) [95]27.2 (−7.9 to 62.3).13.02
≥Medianc280.5 (103.9) [102]310.0 (131.2) [88]−32.4 (−70.2 to 5.5).09
CTX, μg/L
Overall1.30 (0.72) [201]1.21 (0.49) [186]0.07 (−0.07 to 0.21).31
By sexMale1.62 (0.80) [97]1.39 (0.43) [88]0.19 (0.00 to 0.38).048.03
Female0.99 (0.48) [104]1.05 (0.48) [98]−0.09 (−0.23 to 0.06).23
By baseline 25(OH)D3 concentrationb<75 nmol/L1.24 (0.70) [103]1.18 (0.50) [94]0.07 (−0.09 to 0.24).39.98
≥75 nmol/L1.34 (0.77) [59]1.28 (0.52) [54]0.06 (−0.18 to 0.30).61
By calcium intake<Medianc1.37 (0.77) [94]1.27 (0.45) [95]0.04 (−0.15 to 0.23)..69.53
≥Medianc1.22 (0.69) [101]1.14 (0.52) [88]0.11 (−0.08 to 0.31).26
P1NP, μg/L
Overall726.5 (408.7) [201]692.8 (334.9) [186]46.2 (−38.2 to 130.5).28
By sexBoys928.8 (418.8) [97]816.5 (315.1) [88]106.6 (−8.8 to 222.1).07.049
Girls537.9 (294.1) [104]581.8 (313.8) [98]−19.1 (−104.3 to 66.1).66
By baseline 25(OH)D3 concentrationb<75 nmol/L665.3 (362.8) [103]658.3 (361.5) [94]10.7 (−89.1 to 110.6).83.26
≥75 nmol/L795.6 (472.4) [59]690.4 (309.9) [54]101.2 (−46.0 to 248.4).18
By calcium intake<Medianc800.2 (447.6) [94]699.0 (307.6) [95]109.8 (−17.1 to 236.6).09.16
≥Medianc659.2 (365.8) [101]678.6 (362.3) [88]−4.7 (−116.7 to 107.3).93
Vitamin D arm: mean value (SD) [N]Placebo arm: mean value (SD) [N]Adjusted mean difference (95% CI)aPP for interaction
25(OH)D3, nmol/L
Overall97.6 (21.5) [202]58.8 (14.2) [187]39.9 (36.1 to 43.6)<.001—
By sexMale99.8 (22.9) [97]62.7 (13.5) [88]39.7 (33.9 to 45.4)<.001.89
Female95.6 (20.0) [105]55.3 (14.1) [99]40.1 (35.5 to 44.7)<.001
By baseline 25(OH)D3 concentrationb<75 nmol/L98.8 (20.6) [94]57.9 (14.4) [95]43.3 (38.2 to 48.3)<.001.04
≥75 nmol/L95.7 (20.5) [102]59. 8 (14.2) [89]35.6 (30.4 to 40.7)<.001
By calcium intake<Medianc92.4 (19.3) [103]53.7 (13.8) [94]37.7 (33.2 to 42.2)<.001.11
≥Medianc107.9 (22.8) [60]65.0 (12.3) [54]44.3 (37.7 to 50.9)<.001
Adjusted calcium, mmol/L
Overall2.28 (0.07) [201]2.27 (0.07) [186]0.01 (0.00 to 0.03).06
By sexMale2.28 (0.07) [97]2.27 (0.07) [88]0.02 (0.00 to 0.04).12.59
Female2.27 (0.07) [104]2.27 (0.06) [98]0.01 (−0.01 to 0.03).32
By baseline 25(OH)D3 concentrationb<75 nmol/L2.28 (0.07) [94]2.27 (0.07) [95]0.01 (−0.01 to 0.03).34.70
≥75 nmol/L2.27 (0.07) [101]2.27 (0.06) [88]0.02 (0.00 to 0.04).08
By calcium intake<Medianc2.28 (0.07) [103]2.27 (0.07) [94]0.01 (−0.01 to 0.03).22.64
≥Medianc2.29 (0.08) [59]2.27 (0.06) [54]0.02 (−0.01 to 0.04).12
PTH, pmol/L
Overall4.18 (1.77) [201]4.51 (1.86) [186]−0.55 (−0.94 to −0.17).005
By sexMale4.14 (1.75) [97]4.20 (1.74) [88]−0.22 (−0.76 to 0.32).43.10
Female4.23 (1.80) [104]4.78 (1.92) [98]−0.83 (−1.38 to −0.29).003
By baseline 25(OH)D3 concentrationb<75 nmol/L4.43 (1.79) [103]4.92 (1.96) [94]−0.57 (−1.07 to −0.06).03.73
≥75 nmol/L3.93 (1.95) [59]4.21 (1.63) [54]−0.52 (−1.08 to 0.04).07
By calcium intake<Medianc4.22 (1.84) [94]4.38 (1.80) [95]−0.48 (−1.05 to 0.09).10.74
≥Medianc4.17 (1.72) [101]4.63 (1.95) [88]−0.58 (−1.13 to −0.04).04
Total ALP, IU/L
Overall303.5 (111.6) [202]302.5 (116.9) [186]−5.2 (−30.8 to 20.5).69
By sexMale361.9 (93.4) [97]349.2 (120.4) [88]0.4 (−30.7 to 31.6).98.37
Female249.5 (99.6) [105]260.6 (96.5) [98]−17.4 (−46.0 to 11.3).23
By baseline 25(OH)D3 concentrationb<75 nmol/L284.1 (107.6) [103]305.1 (132.6) [94]−19.2 (−52.5 to 14.2).26.18
≥75 nmol/L323.3 (117.0) [60]300.7 (99.5) [54]10.3 (−26.9 to 47.5).59
By calcium intake<Medianc328.5 (116.4) [94]295.4 (103.2) [95]27.2 (−7.9 to 62.3).13.02
≥Medianc280.5 (103.9) [102]310.0 (131.2) [88]−32.4 (−70.2 to 5.5).09
CTX, μg/L
Overall1.30 (0.72) [201]1.21 (0.49) [186]0.07 (−0.07 to 0.21).31
By sexMale1.62 (0.80) [97]1.39 (0.43) [88]0.19 (0.00 to 0.38).048.03
Female0.99 (0.48) [104]1.05 (0.48) [98]−0.09 (−0.23 to 0.06).23
By baseline 25(OH)D3 concentrationb<75 nmol/L1.24 (0.70) [103]1.18 (0.50) [94]0.07 (−0.09 to 0.24).39.98
≥75 nmol/L1.34 (0.77) [59]1.28 (0.52) [54]0.06 (−0.18 to 0.30).61
By calcium intake<Medianc1.37 (0.77) [94]1.27 (0.45) [95]0.04 (−0.15 to 0.23)..69.53
≥Medianc1.22 (0.69) [101]1.14 (0.52) [88]0.11 (−0.08 to 0.31).26
P1NP, μg/L
Overall726.5 (408.7) [201]692.8 (334.9) [186]46.2 (−38.2 to 130.5).28
By sexBoys928.8 (418.8) [97]816.5 (315.1) [88]106.6 (−8.8 to 222.1).07.049
Girls537.9 (294.1) [104]581.8 (313.8) [98]−19.1 (−104.3 to 66.1).66
By baseline 25(OH)D3 concentrationb<75 nmol/L665.3 (362.8) [103]658.3 (361.5) [94]10.7 (−89.1 to 110.6).83.26
≥75 nmol/L795.6 (472.4) [59]690.4 (309.9) [54]101.2 (−46.0 to 248.4).18
By calcium intake<Medianc800.2 (447.6) [94]699.0 (307.6) [95]109.8 (−17.1 to 236.6).09.16
≥Medianc659.2 (365.8) [101]678.6 (362.3) [88]−4.7 (−116.7 to 107.3).93

N, number.

a

Adjusted for baseline value and school of attendance.

bDeseasonalized values.

cMedian calcium intake 466 mg/d.

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