Table 2.
Respiratory Infection.
| Variable | Vitamin D | Placebo | Adjusted Risk Ratio (95% CI)* |
|---|---|---|---|
| Tuberculosis infection according to positive QFT result† | |||
| Interferon-γ level ≥0.35 IU/ml — no./total no. (%)‡ | |||
| Overall | 147/4074 (3.6) | 134/4043 (3.3) | 1.10 (0.87–1.38)§ |
| Baseline 25(OH)D level <10 ng/ml | 64/1288 (5.0) | 64/1304 (4.9) | 1.01 (0.72–1.42) |
| Baseline 25(OH)D level ≥10 ng/ml | 83/2785 (3.0) | 70/2736 (2.6) | 1.17 (0.86–1.61) |
| Interferon-γ level ≥4.0 IU/ml — no./total no. (%) | |||
| Overall | 23/4074 (0.6) | 35/4043 (0.9) | 0.67 (0.39–1.12) |
| Baseline 25(OH)D level <10 ng/ml | 7/1288 (0.5) | 17/1304 (1.3) | 0.41 (0.17–0.99) |
| Baseline 25(OH)D level ≥10 ng/ml | 16/2785 (0.6) | 18/2736 (0.7) | 0.90 (0.46–1.77) |
| Tuberculosis disease status¶ | |||
| Starting treatment for tuberculosis disease — no./ total no. (%) | |||
| Overall | 21/4401 (0.5) | 25/4418 (0.6) | 0.87 (0.49–1.55) |
| Baseline 25(OH)D level <10 ng/ml | 10/1387 (0.7) | 15/1414 (1.1) | 0.67 (0.30–1.47) |
| Baseline 25(OH)D level ≥10 ng/ml | 11/3013 (0.4) | 10/3000 (0.3) | 1.17 (0.50–2.75) |
| Confirmed or probable tuberculosis disease, as adjudicated by the trial end-point committee — no./total no. (%) | |||
| Overall | 13/4401 (0.3) | 13/4418 (0.3) | 1.05 (0.49–2.27) |
| Baseline 25(OH)D level <10 ng/ml | 6/1387 (0.4) | 8/1414 (0.6) | 0.75 (0.26–2.14) |
| Baseline 25(OH)D level ≥10 ng/ml | 7/3013 (0.2) | 5/3000 (0.2) | 1.47 (0.47–4.61) |
| Acute respiratory infection¶ | |||
| Participant hospitalized for ≥1 episode — no./total no. (%) | |||
| Overall | 29/4401 (0.7) | 34/4418 (0.8) | 0.86 (0.52–1.40) |
| Baseline 25(OH)D level <10 ng/ml | 8/1387 (0.6)‖ | 10/1414 (0.7)** | 0.81 (0.32–2.09) |
| Baseline 25(OH)D level ≥10 ng/ml | 21/3013 (0.7)†† | 24/3000 (0.8)‡‡ | 0.86 (0.48–1.55) |
| Participant reported ≥1 episode — no./total no. (%) | |||
| Overall | 3783/4401 (86.0) | 3793/4418 (85.9) | 1.00 (0.98–1.02) |
| Baseline 25(OH)D level <10 ng/ml | 1195/1387 (86.2) | 1205/1414 (85.2) | 1.01 (0.98–1.04) |
| Baseline 25(OH)D level ≥10 ng/ml | 2587/3013 (85.9) | 2585/3000 (86.2) | 1.00 (0.98–1.02) |
| Participant received ≥1 course of antibiotics for episode — no./total no. (%) | |||
| Overall | 1272/4401 (28.9) | 1292/4418 (29.3) | 0.99 (0.93–1.05) |
| Baseline 25(OH)D level <10 ng/ml | 392/1387 (28.3) | 399/1414 (28.2) | 0.99 (0.88–1.12) |
| Baseline 25(OH)D level ≥10 ng/ml | 880/3013 (29.2) | 892/3000 (29.7) | 0.98 (0.91–1.06) |
The risk ratios were adjusted for school of attendance.
Data for the baseline 25(OH)D level were unavailable for 4 children included in the overall analysis of QFT results (1 of 4074 children in the vitamin D group and 3 of 4043 children in the placebo group).
The primary outcome was a positive QFT result, as defined by an interferon-γ level that was at or above the threshold value of 0.35 IU per milliliter, expressed as a proportion of children.
P = 0.42.
Data for the baseline 25(OH)D level were unavailable for 5 children included in the overall analysis of tuberculosis disease and acute respiratory infection (1 of 4401 children in the vitamin D group and 4 of 4418 children in the placebo group).
A total of 5 children had lower respiratory infections, and 3 had upper respiratory infections.
A total of 9 children had lower respiratory infections, and 1 had an upper respiratory infection.
A total of 18 children had lower respiratory infections, and 3 had upper respiratory infections.
A total of 21 children had lower respiratory infections, and 3 had upper respiratory infections.