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Table 2 Changes in measured clinical variables from baseline to study completion

From: Vitamin D accelerates clinical recovery from tuberculosis: results of the SUCCINCT Study [Supplementary Cholecalciferol in recovery from tuberculosis]. A randomized, placebo-controlled, clinical trial of vitamin D supplementation in patients with pulmonary tuberculosis’

Measured disease parameter(s)

Randomization

p-value (95% CI)

 

Drug intervention (n = 132)

Placebo intervention (n = 127)

 

TB Severity (clinical assessment)

Mean Δ in TB score (points) ± SD, (95 CI)

- 3.19 ± 2.37, (−3.61, -2.75)

- 2.79 ± 2.44, (−3.23, -2.34)

0.198

Mean Δ in weight (kg), (95% CI)

+ 4.02, (3.18 – 4.86)

+ 2.61, (1.99 – 3.23)

0.007

Mean Δ in BMI, (95% CI)

+ 1.48, (1.17 – 1.78)

+ 0.96, (0.72 – 1.20)

0.008

Mean Δ in MUAC (cm), (95% CI)

+ 1.34, (0.74 – 1.64)

+ 0.97, (0.68 – 1.26)

0.079

Chest X-Ray Involvement

Mean no. of zones1 involved ± SD

1.35 ± 1.13

1.82 ± 1.35

0.004

Sputum Smear

Smear Conversion, no. (%) 2

108 (81.8)

103 (81.1)

0.39

IFN-g levels (pg/ml) mean ± SD

Unstimulated levels

3.9 ±28.7

4.3 ± 45.2

0.325

ESAT6-stimulated*

387 ±920

206 ±665

0.077

MTBs-stimulated*

3092 ±1363

2987 ±1510

0.497

  1. MUAC Mid Upper Arm Circumference; BMI Body Mass Index; 95 CI 95% Confidence Interval; SD Standard Deviation; s-25-(OH) D3 = serum 25-hydroxyvitamin D3.
  2. 1 Division of bilateral ling fields into a total of 6 zones (3 per each lung, ‘zone involvement’ = active parenchymal and cavitary disease, exclusive of old fibrotic scarring. 2 Includes all patients who were expectorating at baseline, and claimed ‘unable to expectorate’ at completion of treatment 12 weeks later. ESAT6 early secreted and T cell activated antigen-6 kDa; MTBs Mycobacterium tuberculosis whole sonicate antigen.
  3. *Denotes cytokine levels after subtraction of background from unstimulated cells.