High-dose Vitamin D3 Supplementation in Children and Young Adults with HIV

Abstract

Background Suboptimal vitamin D status is prevalent in HIV-infected patients and associated with increased risk of disease severity and morbidity. We aimed to determine 12-mo safety and efficacy of daily 7000IU vitamin D3 (vitD3) vs placebo to sustain increased serum 25-hydroxyvitamin D (25(OH)D) and improve immune status in HIV-infected subjects. Methods This was a double-blind trial of perinatally- (PHIV) or behaviorally-acquired (BHIV) HIV-infected subjects (5.0–24.9y). Safety, 25(OH)D-related parameters, and immune status were assessed at baseline, 3, 6, and 12 months. Results Fifty-eight subjects enrolled (67% male, 85% African-American, 64% BHIV) and 50 completed with no safety concerns. In unadjusted analyses, there were no differences between randomization groups at baseline; at 3, 6, and 12 months, 25(OH)D was higher with supplementation than baseline and higher than with placebo (P<0.05). In adjusted mixed models, in the supplementation group, the fixed effect of 25(OH)D was higher (P<0.001). Percentage of naïve T helper cells (Th naïve%) were significantly (P<0.01) and T helper cells (CD4%) marginally (P<0.10) increased with supplementation in those taking highly active antiretroviral therapy (HAART), and RNA viral load was reduced (P ≤ 0.05). In exploratory linear models, change in 25(OH)D predicted RNA viral load at 3 and 12 months and CD4% at 3 months (P<0.05). Conclusions Daily 7000IU vitD3 for 12 months was safe in HIV-infected subjects and effective in increasing 25(OH)D. Supplementation improved in some clinically important HIV immune markers in subjects on HAART. Adjunct therapy with high-dose, daily vitD3 for HIV-infected subjects and for those on/off HAART requires further investigation.

Bone health in HIV-infected children and adolescents

“…Few randomized, placebo-controlled trials of vitamin D supplementation have been conducted in HIV-infected children and adolescents 24–28 , and only two studies to date have evaluated bone changes with supplementation 24,27 . In Eckard, et al , authors investigated changes in BMD after 12 months of supplementation in 102 HIV-infected youth 8–26 years old on ART with baseline 25(OH)D ≤30 ng/mL 27 .…”

“…Another recent study performed on a cohort of 58 HIV-infected youths assessed the effect of a daily high-dose supplementation with 7,000 IU of vitamin D 28 . An interesting finding was related to the unchanged parathyroid hormone (PTH) concentration observed despite the increase in 25(OH)D. The majority of subjects were vitamin D deficient at baseline, so one would have expected a decrease in PTH with vitamin D supplementation which was not the case.…”

Comprehensive Safety Monitoring of 12‐Month Daily 7000‐IU Vitamin D3 Supplementation in Human Immunodeficiency Virus–Infected Children and Young Adults

“…1 In a randomized trial of 58 HIV-infected children and young adults, we showed that those supplemented with daily 7000-IU vitD 3, compared with placebo, had not only increased 25(OH)D but also an improved HIV immune profile. 2 Over the 12-month follow-up, 25(OH)D was maintained at an average of 29.8 ± 1.9 ng/mL (least squares mean ± SE) with supplementation, compared with 17.7 ± 2.0 ng/mL for the placebo group (P < .001). The percentage of naïve T-helper cells were significantly increased; T-helper cells marginally increased with supplementation in those taking combination antiretroviral therapy (cART); and there was a significantly reduced RNA viral load.…”

Vitamin D supplementation for preventing infections in children under five years of age

“…In this trial, the vitamin D concentrations were higher in the intervention group for most of the study duration but were not different at the last measurement that was four months after the last dose. Also, whether the intermittent bolus therapy of vitamin D as used in this trial may be more efficient than a regimen of daily therapy in increasing serum vitamin D concentrations is still uncertain as the evidence is mixed (Emel 2012; Tan 2015). In conclusion, there appears to be no benefit of vitamin D with regard to preventing infections, that is pneumonia and diarrhoea.…”