Table 1.
Baseline characteristics of the intention-to-treat population (n=4,000)
| Vitamin D3 (n=2,001) | Placebo (n=1,999) | |
|---|---|---|
| Sex | ||
| Female | 1367 (68%) | 1368 (68%) |
| Male | 634 (32%) | 631 (32%) |
| Age (years) | 38.6 (9.8) | 38.8 (10.0) |
| Education* | ||
| No formal education | 308 (15%) | 327 (16%) |
| Primary | 1294 (64%) | 1294 (65%) |
| Secondary/ advanced | 398 (20%) | 377 (19%) |
| Body mass index (kg/m2)* | ||
| <18.5 | 440 (22%) | 404 (20%) |
| 18.5–24.9 | 1038 (52%) | 1064 (53%) |
| ≥25.0 | 521 (26%) | 531 (27%) |
| CD4 T-cell count (cells per μL) | ||
| < 200 | 866 (43%) | 845 (42%) |
| 200–349 | 461 (23%) | 445 (22%) |
| 350–499 | 300 (15%) | 333 (17%) |
| ≥ 500 | 284 (14%) | 278 (14%) |
| Missing | 90 (5%) | 98 (5%) |
| WHO HIV disease stage | ||
| I / II | 744 (37%) | 760 (38%) |
| III | 1161 (58%) | 1143 (57%) |
| IV | 96 (5%) | 96 (5%) |
| Baseline pulmonary TB | 189 (10%) | 175 (9%) |
| Isoniazid preventive therapy (IPT) | 35 (2%) | 27 (1%) |
| ART regimen | ||
| Efavirenz/lamivudine/tenofovir (EFV/3TC/TDF) | 1940 (97%) | 1943 (97%) |
| Other ART regimen | 61 (3%) | 56 (3%) |
| Mean days from vitamin D screening to randomization | 10.1 (8%) | 10.2 (9%) |
| Vitamin D status at screening visit | ||
| Insufficient, 25(OH)D 20.0–30.0 ng/mL | 955 (48%) | 972 (49%) |
| Moderate deficiency, 25(OH)D 10.0–19.9 ng/mL | 920 (46%) | 865 (43%) |
| Severe deficiency, 25(OH)D 0–9.9 ng/mL | 126 (6%) | 162 (8%) |
Data are n (%), mean (SD).
*
Data not available for all randomized participants