Comprehensive Safety Monitoring of 12-Month Daily 7000-IU Vitamin D3 Supplementation in Human Immunodeficiency Virus–Infected Children and Young Adults. (September 2016)

• Record Type: Journal Article
• Authors: Schall, Joan I.; Hediger, Mary L.; Zemel, Babette S.; Rutstein, Richard M.; Stallings, Virginia A.
• Is Part Of: JPEN, Journal of parenteral and enteral nutrition. Volume 40:Number 7(2016)
• Page Start: 1057
• Page End: 1063
• Publication Date: 2016-09
• Subjects: vitamin D -- safety -- metabolic outcomes -- HIV infection -- children -- young adults; Parenteral feeding -- Periodicals; Enteral feeding -- Periodicals; 615.85484
• DOI: 10.1177/0148607115593790
• Languages: English
• ISSNs: 0148-6071

Abstract

Background : There is uncertainty whether long-term daily dosing with vitamin D3 (cholecalciferol) supplementation (vitD3 ) above the 4000-IU/d dietary reference intake upper tolerable limit in children and adults is safe. As part of a randomized placebo-controlled trial, we determined if supplementation with 7000-IU/d vitD3 for 12 months in human immunodeficiency virus (HIV)–Infected subjects was safe and/or associated with metabolic outcomes. Material and Methods : A total of 58 HIV-infected subjects—aged 9–24.9 years and stratified by mode of HIV acquisition (perinatal or behavioral)—were recruited, randomized to 7000-IU/d vitD3 or placebo, and followed at 3, 6, and 12 months with physical examinations, blood and urine sampling for measures of 25(OH)D (serum 25-hydroxyvitamin D), metabolic status, safety measures, and HIV immune status. Safety was defined by a low incidence (<5%) of the study-defined serious adverse events—that is, elevated serum calcium plus 25(OH)D >160 ng/mL—and no changes in hematologic, liver, renal, metabolic, lipid, or inflammatory status. Results : Randomization groups did not differ in demographic characteristics, vitamin D status, or HIV disease status at baseline. Over the 12 months, serum 25(OH)D increased with supplementation. No subject experienced a serious adverse safety event; none had 25(OH)D >80 ng/mL at any time. There were no clinically significant changes in hematologic, liver, renal, metabolic, lipid, or inflammatory status. Conclusions : Safety of daily 7000-IU vitD3 supplementation in children and young adults with HIV was comprehensively monitored over 12 months. High-dose daily vitD3 supplementation was efficacious in improving vitamin D status, and there were no safety events.