TABLE 3:
Calcium and vitamin D treatment and the risk of serrated polyps during treatment and observational phase
| Outcome | Treatment phase: n=20581 | Observational: n=11082 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N with event/N followed (%) | Crude RR (95% CI) | p | Adjusted3 aRR (95% CI) | p | N with event/Nfollowed (%) | Crude RR (95% CI) | p | Adjusted3 aRR (95% CI) | p | |
| Any serrated polyp | ||||||||||
| No Vitamin D | 278/1031 (27.0) | Reference | Reference | 159/550 (28.9) | Reference | Reference | ||||
| Vitamin D | 287/1027 (28.0) | 1.04 (0.90–1.19) | 0.62 | 1.01 (0.87–1.17) | 0.90 | 170/558 (30.5) | 1.05 (0.88–1.26) | 0.57 | 1.04 (0.86–1.25) | 0.71 |
| No Calcium | 203/763 (26.6) | Reference | Reference | 114/418 (27.3) | Reference | Reference | ||||
| Calcium | 231/764 (30.2) | 1.14 (0.97–1.33) | 0.12 | 1.15 (0.98–1.36) | 0.10 | 136/428 (31.8) | 1.17 (0.95–1.44) | 0.15 | 1.21 (0.97–1.50) | 0.09 |
| Placebo | 99/378 (26.2) | Reference | Reference | 56/205 (27.3) | Reference | Reference | ||||
| Vitamin D + Calcium | 117/384 (30.5) | 1.16 (0.93–1.46) | 0.19 | 1.15 (0.92–1.46) | 0.23 | 72/218 (33.0) | 1.21 (0.90–1.62) | 0.20 | 1.24 (0.92–1.67) | 0.16 |
| Any HP | ||||||||||
| No Vitamin D | 249/1029 (24.2) | Reference | Reference | 132/548 (24.1) | Reference | Reference | ||||
| Vitamin D | 245/1027 (23.9) | 0.99 (0.85–1.15) | 0.86 | 0.96 (0.82–1.13) | 0.65 | 139/555 (25.1) | 1.04 (0.85–1.28) | 0.71 | 1.03 (0.83–1.27) | 0.80 |
| No Calcium | 176/763 (23.1) | Reference | Reference | 101/418 (24.2) | Reference | Reference | ||||
| Calcium | 204/763 (26.7) | 1.16 (0.97–1.38) | 0.10 | 1.18 (0.99–1.42) | 0.07 | 103/423 (24.4) | 1.01 (0.79–1.28) | 0.95 | 1.05 (0.82–1.35) | 0.71 |
| Placebo | 87/378 (23.0) | Reference | Reference | 50/205 (24.4) | Reference | Reference | ||||
| Vitamin D + Calcium | 102/384 (26.6) | 1.15 (0.90–1.48) | 0.26 | 1.16 (0.90–1.49) | 0.26 | 53/215 (24.7) | 1.01 (0.72–1.42) | 0.95 | 1.03 (0.73–1.45) | 0.87 |
| Any SSA/P | ||||||||||
| No Vitamin D | 42/1008 (4.2) | Reference | Reference | 26/536 (4.9) | Reference | Reference | ||||
| Vitamin D | 58/1006 (5.8) | 1.38 (0.94–2.04) | 0.10 | 1.27 (0.86–1.88) | 0.22 | 36/550 (6.6) | 1.35 (0.83–2.20) | 0.23 | 1.31 (0.82–2.10) | 0.26 |
| No Calcium | 36/745 (4.8) | Reference | Reference | 13/409 (3.2) | Reference | Reference | ||||
| Calcium | 39/740 (5.3) | 1.09 (0.70–1.70) | 0.70 | 1.03 (0.66–1.60) | 0.91 | 36/417 (8.6) | 2.72 (1.47–5.03) | 0.001 | 2.66 (1.44–4.89) | 0.002 |
| Placebo | 14/369 (3.8) | Reference | Reference | 5/201 (2.5) | Reference | Reference | ||||
| Vitamin D + Calcium | 21/372 (5.7) | 1.49 (0.77–2.88) | 0.24 | 1.26 (0.67–2.39) | 0.47 | 22/216 (10.2) | 4.09(1.60–10.50) | 0.003 | 3.82 (1.26–11.57) | 0.02 |
Analyses of no vitamin D vs. vitamin D include all randomized participants; analyses of no calcium vs. calcium and of neither agent vs. both agents are restricted to full factorial participants.
Subjects who had an exam at least one year after randomization and had sufficient pathology to determine at least one of the serrated outcomes
Subjects followed after treatment period who had sufficient pathology to determine at least one of the serrated outcomes
Adjusted for age, sex, clinical center, race (white, black, other/missing), BMI, smoking status (never, former, current), anticipated surveillance interval (3 or 5 years; treatment phase only), randomization arm of randomization (2 group or full factorial), number of baseline serrated polyps (0, 1, 2+). Where necessary due to sparse data, clinical center was grouped by prevalence of serrated lesions at baseline into low (Georgia, Iowa, Minnesota, and California), medium (New Hampshire, Colorado, South Carolina, and Puerto Rico), high (Texas, Ohio, and North Carolina).