Table 1.
Demographics table by arm.
| Patient characteristicsa | Vitamin D (N = 135) | Placebo (N = 71) |
|---|---|---|
| Age at randomization, years, Median (IQR) | 62 (54–70) | 64 (56–71) |
| Male | 57 (42) | 31 (44) |
| Race | ||
| White | 120 (89) | 62 (87) |
| African American | 10 (7) | 5 (7) |
| Other/Unknown race | 5 (4) | 4 (6) |
| Ethnicity | ||
| Hispanic | 10 (8) | 5 (7) |
| Non-Hispanic | 123 (92) | 63 (93) |
| Unknown | 2 | 3 |
| Body Mass Index, kg/m2, Median (IQR) | 29 (25–33) | 29 (25–33) |
| <25 (normal) | 31 (23) | 16 (23) |
| 25–29 (overweight) | 45 (33) | 27 (38) |
| ≥30 (obese) | 59 (44) | 28 (39) |
| Histology | ||
| Marginal Zone Lymphoma | 33 (24) | 14 (20) |
| Small Lymphocytic Lymphoma | 13 (10) | 9 (13) |
| Follicular Lymphoma | 89 (66) | 48 (68) |
| FLIPI Low/Intermediate (0–2) | 62 (70) | 32 (67) |
| FLIPI High (3–5) | 27 (30) | 16 (33) |
| FL Grade 1 | 35 (39) | 21 (44) |
| FL Grade 2 | 44 (49) | 24 (50) |
| FL Grade 3a | 10 (11) | 3 (6) |
| Ann Arbor Stage | ||
| Stage II | 20 (15) | 7 (10) |
| Stage III | 45 (33) | 27 (38) |
| Stage IV | 70 (52) | 37 (52) |
| Baseline Vitamin D, ng/mL, mean [SD]b | 33 [11] | 33 [12] |
| ≤20 (deficient) | 15 (12) | 10 (14) |
| >20–30 (insufficient) | 39 (30) | 18 (26) |
| >30 (sufficient) | 75 (58) | 42 (60) |
| Baseline PTH > ULN (65 pg/mL)c | 3 (2) | 3 (4) |
| Taking vitamin D supplement/multivitamind | 60 (44) | 30 (42) |
a
Frequency (column percent) is reported unless otherwise specified.
b
Baseline vitamin D not measured in 6 patients in the vitamin D arm and 1 in the placebo arm.
c
Baseline PTH not measured in 8 patients in the vitamin D arm and 2 in the placebo arm.
d
Total vitamin D supplementation ≤1000 IU daily permitted per protocol.