Table 1 Baseline characteristics in the vitamin D and placebo study arms (N = 259)
Baseline characteristic | Randomization | |
|---|---|---|
Drug intervention (n = 132) | Placebo intervention (n = 127) | |
Age (years), Mean ± SD | 27.8 ± 13.2 | 28.3 ± 14.1 |
Gender, Men | 71 (53.8) | 70 (55.1) |
Weight (kg), Mean ± SD | 45.2 ± 7.6 | 45.6 ± 9.0 |
BMI, Mean (range) | 17.2 (11–25) | 17.3 (11–27) |
MUAC (cm), (range) | 21.2 (14–30) | 21.1 (15–32) |
Disease Symptom(s)present | ||
Cough | 127 (96.2) | 125 (98.4) |
Haemoptysis | 30 (22.7) | 34 (26.8) |
Dyspnoea | 84 (63.6) | 85 (66.9) |
Chest pain | 84 (63.6) | 84 (66.1) |
Night sweats | 69 (52.3) | 55 (43.3) |
Pale conjunctiva | 70 (53) | 67 (52.8) |
Tachycardia | 87 (65.9) | 86 (67.7) |
Fever | 49 (37.1) | 68 (53.5) |
Crepitations | 50 (37.9) | 38 (29.9) |
Rhonchi | 19 (14.4) | 21 (16.5) |
Reduced breath sounds | 26 (19.7) | 20 (15.7) |
TB score, Mean ± SD, 95 CI | 6.68 ± 2.04, 6.3-7.03 | 6.85 ± 2.50, 6.4-7.29 |
Distribution by Severity Class/TB score* | ||
Class I/0 – 5 | 32 (24.2) | 40 (31.5) |
Class II/6 – 7 | 51 (38.6) | 41 (32.3) |
Class III/≥ 8 | 49 (37.1) | 46 (36.2) |
Serum-25-(OH)D3 levels; Mean, (SD) | 20.58 ± 8.51 | 22.87 ± 10.33 |
25(OH)D3 >30 ng/ml (Optimal) | 18 (13.6) | 25 (19.7) |
25(OH)D3 20-30 ng/ml (Insufficient) | 46 (34.8) | 54 (42.5) |
25(OH)D3 < 20 ng/ml (Deficient) | 70 (53) | 51(41) |
Chest X-Ray Classification1 | ||
Minimally Advanced disease | 10 (7.6) | 13 (10.2) |
Moderately Advanced disease | 77 (58.3) | 62 (48.8) |
Far Advanced disease | 45 (34.1) | 52 (40.9) |
No Cavity | 7 (5.3) | 4 (3.1) |
Cavity size < 4 cm | 60 (45.5) | 59 (46.5) |
Cavity size ≥ 4 cm | 65 (49.2) | 64 (50.4) |
No. of zones involved 3, Mean ± SD | 3.61 ± 1.40 | 3.64 ± 1.48 |
Sputum microbial load (microscopy)2 | ||
Scant, 1–9 AFB/100 fields | 4 (3.0) | 2 (1.6) |
+1, 10–99 AFB/100 fields, | 36 (27.3) | 34 (26.8) |
+2, 1–10 AFB/50 fields, | 25 (18.9) | 23 (18.1) |
+3, >10 AFB/20 fields, | 67 (50.8) | 68 (53.5) |
IFN-g levels (pg/ml) mean ± SD | ||
Unstimulated levels | 0.2 ± 2.6 | 0 ±0 |
ESAT6-stimulated | 413 ±977 | 303 ±804 |
MTBs-stimulated | 2826 ±1391 | 2858 ±1337 |