Table 2.
Safety outcomes, serious adverse events and other adverse events.
| Vitamin D3 600 IU/day (n = 82) | Vitamin D3 5000 IU/day (n = 83) | |
|---|---|---|
| Safety outcome | ||
| Hypercalcaemia | 0 (0) | 0 (0) |
| Nephrolithiasis/ureterolithiasis | 1 (1.2) | 2 (2.4) |
| Serious adverse events, n (%) | ||
| Suicide attempt resulting in hospitalisation | 1 (1.2) | 0 (0) |
| Other unplanned hospitalisation | 4 (4.9) | 15a(18.1) |
| Planned hospitalisation | 1 (1.2) | 3 (3.6) |
| Pregnancy | 6b(7.3) | 3 (3.6) |
| Other adverse events, n (%) | ||
| Upper respiratory infection | 44 (53.7) | 40 (48.2) |
| Numbness or tingling | 22 (26.8) | 21 (25.3) |
| Headache/worsened headache/migraine | 14 (17.1) | 22 (26.5) |
| Fatigue/increased fatigue | 14 (17.1) | 11 (13.3) |
| Joint pain or swelling | 10 (12.2) | 12 (14.5) |
| Myalgia | 11 (13.4) | 7 (8.4) |
| Sinusitis | 12 (14.6) | 5 (6.0) |
| Sleep disorder | 5 (6.1) | 11 (13.3) |
| Depression/increased depression/severe depression | 6 (7.3) | 10 (12.0) |
| Influenza | 7 (8.5) | 6 (7.2) |
| Abdominal pain/cramp/discomfort | 8 (9.8) | 4 (4.8) |
| Nausea | 7 (8.5) | 4 (4.8) |
| Limb pain | 6 (7.3) | 4 (4.8) |
| Cough | 5 (6.1) | 5 (6.0) |
| Urinary tract infection | 7 (8.5) | 3 (3.6) |
| Urinary dysfunction | 3 (3.7) | 6 (7.2) |
| Dizziness/increased dizziness | 4 (4.9) | 5 (6.0) |
| Spasm/cramp (non-abdominal) | 3 (3.7) | 6 (7.2) |
| Bronchitis | 5 (6.1) | 4 (4.8) |
| Anxiety/worsening anxiety | 3 (3.7) | 6 (7.2) |
| Sore throat ( ± streptococcal infection) | 4 (4.9) | 2 (2.4) |
a
Two participants accounted for 11 unplanned hospitalisations; one was admitted 4 times for MS relapse; the other had 7 unplanned hospitalisations, 4 of which were re-admissions following issues after elective surgery. 7 unplanned hospitalisations were for MS relapse and were deemed possibly related to study drug (this was the hypothesis of the trial). MS relapses themselves were not considered adverse events for purposes of this trial and most were managed in the outpatient setting.
b
Includes 2 pregnancies for 1 participant; one additional participant became pregnant during run-in period and was withdrawn prior to randomisation.