Safety and Efficacy of High-Dose Daily Vitamin D3 Supplementation in Children and Young Adults Infected With Human Immunodeficiency Virus

Abstract

Background. Suboptimal vitamin D (vitD) status is common in children and young adults infected with human immunodeficiency virus (HIV). The vitD supplemental dose needed to normalize vitD status in this population is unknown. Methods. In this double-blind trial, subjects infected with HIV ages 8.3 to 24.9 years were randomized to vitD 3 supplementation of 4000 IU/day or 7000 IU/day and evaluated at 6 and 12 week for changes in vitD status and HIV indicators. A dose was considered unsafe if serum calcium was elevated (above age and sex-specific range) associated with elevated serum 25 hydroxyvitamin D (25(OH)D); >160 ng/mL). Results. At baseline, 95% of subjects (n = 44; 43% with perinatally acquired HIV, 57% with behaviorally acquired HIV) had a suboptimal serum 25(OH)D concentration of <32 ng/mL (mean ± standard deviation, 19.3 ± 7.4; range, 4.4-33.6 ng/mL). After 12 weeks (main outcome) of D 3 supplementation, both D 3 doses were safe and well tolerated, with no evidence of elevation of serum calcium concentrations or deterioration in HIV immunologic or virologic status. Sufficient vitD status, defined as serum 25(OH)D 32 ng/mL, was achieved in 81% of all subjects, and only the 7000 IU/day group (86%) achieved this a priori efficacy criterion in >80% of subjects. Change in serum 25(OH)D did not differ between HIV acquisition groups. Conclusions. A 7000 IU/day D 3 supplementation was safe and effective in children and young adults infected with HIV.

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

“…23 The expression of natural cytotoxicity receptors, NKp46, NKp44 and NKp30, on natural killer (NK) cells was measured. 12 …”

“…Medical record reviews documented HIV disease status (CDC classification), 12;24 age at diagnosis and initiation of highly active antiretroviral therapy (HAART). HAART was categorized as protease inhibitor- (PI), non-nucleoside reverse transcriptase inhibitor- (NNRTI), and nucleoside reverse transcriptase inhibitor-based (NRTI) regimens, and whether tenofovir or efavirenz were part of regimens.…”

“…Efficacy, as 25(OH)D ≥32ng/mL in ≥80% of US participants, required 7000IU/d. 12 In Botswana, both dose groups achieved the efficacy criteria.…”

“…5;6 Higher 25(OH)D status is associated with higher CD4 + cell counts 7–9 and lower RNA viral load. 10;11 We reported cholecalciferol (vitD 3 ) dose (4000 and 7000IU/d) selection trials in HIV-infected US youth 12 and in Botswanan youth and adults (Steenhoff AP, 2014, personal communication). In both settings, short-term safety was established and improvements seen in several HIV immune status indicators.…”

Nutrition Therapy for HAART-Naïve HIV-Infected Patients

“…So far, daily intake of 800-2,000 IU vitamin D is recommended to maintain serum 25 (OH)D ≥30 ng/mL [47]. However, a recent clinical trial assures that the ingestion of high daily doses of vitamin D, that is, 7,000 IU, are safe and effective in maintaining 25 (OH)D serum levels ≥30 ng/mL [57].…”