Table 2.
Patient demographics and baseline clinical characteristics of patients randomized to receive either ART plus nutritional supplement (NS) or ART alone (Control) for 6 months
|
Characteristics |
|
Nutritional supplement |
Control |
p value |
Completers* |
Non-completers* |
p value |
|---|---|---|---|---|---|---|---|
| n = 19 | n = 19 | n = 26 | n = 12 | ||||
| Gender – Male |
n,% |
6 (31.6%) |
7 (36.8%) |
0.732 |
8 (30.8%) |
5 (41.7%) |
0.510 |
| Age (years) |
Median (IQR) |
37 (32 – 42) |
34 (30 – 43) |
0.612 |
37 (32 – 42) |
34.5 (31.5 – 42.5) |
0.505 |
| Employed |
n,% |
14 (73.7%) |
11 (57.9%) |
0.456 |
15 (57.7%) |
10 (83.3%) |
0.122 |
| Education |
|
|
|
|
|
|
|
| < Grade 8 |
n,% |
2 (10.5%) |
1 (5.3%) |
0.222 |
1 (3.8%) |
1 (8.3%) |
0.114 |
| ≥ Grade 8 |
n,% |
17 (89.5%) |
18 (94.7%) |
|
24 (92.3%) |
11 (91.7%) |
|
| Self-reported weight loss (kg) |
Median (IQR) |
5 (3 – 5) |
5 (2 – 9) |
0.094 |
5 (3 – 8) |
5 (4 – 7) |
0.356 |
| Body mass index (BMI; kg/m2) |
Median (IQR) |
20.4 (18.0 – 22.4) |
19.3 (18.4 – 21.3) |
0.197 |
20.2 (17.6 – 21.7) |
19.7 (18.0 – 21.7) |
0.842 |
| < 18.5 kg/m2 |
n,% |
6 (31.6%) |
4 (21.1%) |
0.461 |
6 (23.1%) |
1 (8.3%) |
0.234 |
| Fat (kg) |
Median (IQR) |
10.6 (10.0 – 17.7) |
11.1 (5.5 – 15.5) |
0.560 |
11.1 (9.1 – 15.9) |
10.5 (8.6 – 12.0) |
0.791 |
| Systolic blood pressure (mmHg) |
Median (IQR) |
104 (90 – 125) |
111 (107 – 127) |
0.079 |
111 (102 – 127) |
107 (95 – 120) |
0.354 |
| Diastolic blood pressure (mmHg) |
Median (IQR) |
69 (46 – 76) |
71 (66 – 84) |
0.209 |
71 (66 – 87) |
68 (56 – 75) |
0.209 |
| WHO stage III/IV |
n,% |
4/12 (33.3%) |
7/16 (43.8%) |
0.611 |
7/19 (36.8%) |
4/9 (44.4%) |
0.966 |
| ART regimen |
|
|
|
|
|
|
|
| TDF/3TC/EFV |
n,% |
14 (73.7%) |
14 (73.7%) |
1.000 |
22 (84.6%) |
6 (50.0%) |
0.031 |
| TDF/3TC/NVP |
n,% |
1 (5.3%) |
1 (5.3%) |
|
- |
2 (16.7%) |
|
| d4T/3TC/EFV |
n,% |
4 (21.0%) |
4 (21.0%) |
|
4 (15.4%) |
4 (33.3%) |
|
| CD4 cells/mm3 |
Median (IQR) |
60 (12 – 105) |
107 (63 – 165) |
0.149 |
86 (24 – 125) |
99 (70 – 121) |
0.405 |
| ≤ 50 |
n,% |
8 (42.1%) |
4 (21.0%) |
0.027 |
10 (38.5%) |
2 (16.7%) |
0.152 |
| 51 – 100 |
n,% |
5 (26.3%) |
5 (26.4%) |
|
6 (23.0%) |
4 (33.3%) |
|
| 101 – 200 |
n,% |
6 (31.6%) |
6 (31.6%) |
|
6 (23.0%) |
6 (50.0%) |
|
| > 201 – 350 |
n,% |
0 (0.0%) |
4 (21.0%) |
|
4 (15.5%) |
0 (0.0%) |
|
| Hemoglobin (g/dL) |
Median (IQR) |
10.3 (9.0 – 11.3) |
13.1 (11.1 – 14.7) |
0.001 |
11.6 (10.3 – 13.6) |
11.0 (9.4 – 12.6) |
0.294 |
| < 10 g/dL |
n,% |
9 (47.4%) |
1 (5.3%) |
0.009 |
5 (19.2%) |
5 (41.7%) |
0.144 |
| Viral load (log10) |
Median (IQR) |
5.4 (4.7 – 5.8) |
5.6 (5.4 – 6.0) |
0.042 |
5.5 (4.7 – 5.8) |
5.2 (4.9 – 5.6) |
0.851 |
| Mean cell volume (fL) |
Median (IQR) |
85.0 (78.4 – 98.9) |
91.3 (84.0 – 94.8) |
0.090 |
90.1 (81.5 – 94.6) |
83.2 (78.3 – 88.0) |
0.096 |
| TB at initiation |
n,% |
2 (10.5%) |
0 (0.0%) |
0.157 |
1 (4.4%) |
1 (8.3%) |
0.629 |
| Alcohol (current/history) |
n,% |
8 (42.1%) |
4 (21.1%) |
0.045 |
8 (30.8%) |
4 (33.3%) |
0.846 |
| Smoking (current/history) | n,% | 5/19 (26.3%) | 1/18 (5.6%) | 0.063 | 3/26 (11.5%) | 2/11 (18.2%) | 0.409 |
*Patient demographics and baseline clinical characteristics of those that completed (completers) and those that did not complete the 6 month follow-up (non-completers) were compared.