Table 1.
Baseline Characteristics
| Median (Q1, Q3) or no. (%) | Total HIV+ Group (N=102) |
Supplementation Dose* (N=66) |
Standard Dose** (N=36) |
P† |
|---|---|---|---|---|
| Age, years | 20.3 (16.6, 22.8) | 20.9 (17.0, 23.6) | 19.9 (15.9, 21.6) | 0.27 |
| BMI, kg/m2 | 22.5 (19.5, 25.3) | 23 (20, 26) | 21.1 (18.9, 21.6) | 0.07 |
| Male sex | 65 (64%) | 44 (67%) | 21 (58%) | 0.52 |
| Black race | 91 (89%) | 57 (86%) | 34 (94%) | 0.32 |
| Tanner stage | 0.96 | |||
| 1 | 4 (4%) | 2 (3%) | 2 (6%) | |
| 2–4 | 21 (21%) | 13 (20%) | 8 (22%) | |
| 5 | 77 (75%) | 51 (77%) | 26 (72%) | |
| Current smoking | 27 (27%) | 22 (33%) | 5 (14%) | 0.04 |
| Perinatal transmission | 54 (53%) | 35 (47%) | 19 (53%) | 0.68 |
| HIV duration, years | 8.1 (2.3, 15.6) | 8.2 (2.1, 15.8) | 8.0 (2.7, 15.6) | 0.86 |
| ARV duration, years | 3.2 (1.3, 10.0) | 3.2 (1.3, 10.0) | 2.7 (1.3, 10.1) | 1.00 |
| NRTI duration, years | 3.1 (1.3, 9.5) | 3.2 (1.3, 9.7) | 2.6 (1.3, 7.7) | 0.84 |
| Current use of EFV | 27 (25%) | 18 (27%) | 9 (25%) | 1.00 |
| Current use of TDF | 82 (80%) | 55 (83%) | 27 (75%) | 0.31 |
| Current CD4, cells/mm3 | 652 (449, 872) | 652 (451, 879) | 608 (417, 792) | 0.58 |
| Nadir CD4, cells/mm3 | 293 (174, 424) | 317 (190, 472) | 246 (109, 363) | 0.06 |
| HIV RNA, <80 copies/mL | 91 (89%) | 59 (89%) | 32 (89%) | 1.00 |
| HIV RNA, copies/mL (N=11) | 190 (127, 630) | 143 (90, 590) | 654 (382, 805) | 0.10 |
| 25(OH)D, ng/mL | 17 (13, 22) | 18.0 (14.0, 22.0) | 17.3 (11.03, 20.9) | 0.49 |
| PTH, pg/mL | 55.1 (40.7, 74.9) | 53.4 (39.8, 74.9) | 58.1 (44.9, 72.2) | 0.40 |
| Spine BMD, g/cm2 | 1.13 (0.95, 1.24) | 1.17 (1.06, 1.27) | 1.13 (0.89, 1.27) | 0.29 |
| Hip BMD, g/cm2 | 1.05 (0.85, 1.16) | 1.10 (0.90, 1.22) | 0.98 (0.88, 1.13) | 0.05 |
| Spine z-score | −0.5 (−1.4, 0.4) | −0.3 (−1.1, 0.4) | −0.6 (−1.5, 0.2) | 0.31 |
| Hip z-score | −0.5 (−1.4, 0.4) | −0.4 (−0.9, 0.5) | −0.9 (−1.7, −0.2) | 0.04 |
| Osteocalcin, ng/mL | 33.7 (24.6, 49.5) | 33.7 (25.6, 49.5) | 32.8 (22.5, 47.9) | 0.61 |
| B-CrossLaps, ng/mL | 0.82 (0.57, 1.14) | 0.81 (0.59, 1.09) | 0.82 (0.54, 1.25) | 0.85 |
| P1NP, ng/mL‡ | 99.7 (76.8, 150.0) | 99.7 (76.8, 150.0) | 99.8 (73.3, 165.8) | 0.99 |
Supplementation dose = 60,000 IU/month (moderate dose) or 120,000 IU/month (high dose);
Standard dose = 18,000 IU/month (control dose);
P value between supplementation and standard dosing arms;
The upper limit of detection for P1NP was 300 ng/mL. Overall, 21% of subjects had unmeasurable values above the upper limit (21.5% vs. 19.4% in supplementation vs. standard arms, respectively; P=0.80) and were assigned a value of 300 ng/mL for analysis, resulting in a truncated, non-normal distribution. N.B. Bold-faced P values indicate those <0.05.
Q, quartile; BMI, body mass index; HIV, human immunodeficiency virus; ARV, antiretroviral; NRTI, nucleoside reverse transcriptase inhibitor; EFV, efavirenz; TDF, tenofovir; 25(OH)D, 25-hydroxyvitamin D; PTH, parathyroid hormone; BMD, bone mineral density; P1NP, procollagen type 1 amino-terminal propeptide