Table 4.
Adverse Events and Attrition
| All (n = 63) | Treatment Arms |
P Value | ||
|---|---|---|---|---|
| A (n = 32) | B (n = 31) | |||
| Adverse events | ||||
| Subjects with any clinical adverse event | 34 (54%) | 19 (59%) | 15 (48%) | .38 |
| Clinical AEs per subject | ||||
| n | 34 | 19 | 15 | |
| Mean ± SD | 3.3 ± 2.7 | 3.2 ± 3.1 | 3.5 ± 2.1 | .69 |
| Range | 1–13 | 1–13 | 1–8 | |
| Specific adverse events | ||||
| Clinical (at any visit) | ||||
| Drowsiness | 9 (14%) | 4 (13%) | 5 (16%) | .73 |
| Increased thirst | 9 (14%) | 4 (13%) | 5 (16%) | .73 |
| Nausea | 9 (14%) | 5 (16%) | 4 (13%) | 1.00 |
| Dryness of mouth | 8 (13%) | 5 (16%) | 3 (10%) | .71 |
| Headache (persistent) | 7 (11%) | 5 (16%) | 2 (6%) | .43 |
| Unusual tiredness or weakness | 7 (11%) | 4 (13%) | 3 (10%) | 1.00 |
| Constipation | 6 (10%) | 2 (6%) | 4 (13%) | .43 |
| Loss of appetite | 6 (10%) | 4 (13%) | 2 (6%) | .67 |
| Bone pain | 5 (8%) | 3 (9%) | 2 (6%) | 1.00 |
| Vomiting | 4 (6%) | 3 (9%) | 1 (3%) | .61 |
| Muscle pain | 3 (5%) | 3 (9%) | 0 (0%) | .24 |
| Increased frequency of urination | 3 (5%) | 2 (6%) | 1 (3%) | 1.00 |
| Itching skin | 3 (5%) | 2 (6%) | 1 (3%) | 1.00 |
| Metallic taste | 3 (5%) | 2 (6%) | 1 (3%) | 1.00 |
| Increased sensitivity of eyes to light or irritation of eyes | 2 (3%) | 1 (3%) | 1 (3%) | 1.00 |
| Calcium deposits in tissues outside the bone | 1 (2%) | 0 (0%) | 1 (3%) | .49 |
| Laboratory | ||||
| Serum Ca > 10.5 mg/dL at any visit | 0 (0%) | 0 (0%) | 0 (0%) | – |
| Serum P > 5.7 mg/dL at any visit | 2 (3%) | 1 (3%) | 1 (3%) | 1.00 |
| UCa/cr > 0.20 at any visit | 20 (32%) | 11 (34%) | 9 (29%) | .65 |
| Attrition (n = 63) | .87 | |||
| Completed all study visits | 48 (76%) | 26 (81%) | 22 (71%) | .34 |
| Lost to follow-up | 11 (17%) | 4 (13%) | 7 (23%) | .29 |
| Withdrew consent | 2 (3%) | 1 (3%) | 1 (3%) | .98 |
| Withdrawn by investigator | 2 (3%) | 1 (3%)a | 1 (3%)b | .98 |
| Had all 25OHD values | 34 (54%) | 19 (59%) | 15 (48%) | .38 |
| Compliance per study visitc | ||||
| 3 months (n = 56) | 68 (50, 95) | 70 (52, 94) | 68 (48, 96) | .79 |
| 6 months (n = 53) | 70 (55, 96) | 75 (55, 96) | 69 (49, 100) | .80 |
| 9 months (n = 49) | 71 (56, 100) | 75 (59, 96) | 69 (53, 100) | .70 |
| 12 months (n = 48) | 71 (58, 100) | 75 (55, 96) | 71 (61, 100) | .66 |
a
One participant in arm A was withdrawn by the investigator due to taking large vitamin D supplementation doses, outside the study, and unwilling to discontinue.
b
One participant in arm B was withdrawn by the investigator after reporting nausea, abdominal pain, and anorexia directly after ingesting the study drug. It remains unclear whether these symptoms were IBD related.
c
Missing compliance data assigned to be noncompliant. Values expressed in mean (interquartile range).