Comprehensive Safety Monitoring of 12-Month Daily 7000-IU Vitamin D3Supplementation in Human Immunodeficiency Virus–Infected Children and Young Adults
| Autor: | Virginia A. Stallings, Babette S. Zemel, M L Hediger, Joan I. Schall, Richard M. Rutstein |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Blood Glucose
Male Vitamin medicine.medical_specialty Randomization Adolescent Medicine (miscellaneous) HIV Infections Placebo Young Adult 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine 030225 pediatrics Internal medicine Vitamin D and neurology medicine Humans Insulin 030212 general & internal medicine Dosing Young adult Child Triglycerides Cholecalciferol Nutrition and Dietetics Dose-Response Relationship Drug business.industry C-Reactive Protein Cholesterol chemistry Dietary Reference Intake Dietary Supplements Immunology Calcium Female business |
| Zdroj: | Journal of Parenteral and Enteral Nutrition. 40:1057-1063 |
| ISSN: | 1941-2444 0148-6071 |
| Popis: | 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.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)D160 ng/mL-and no changes in hematologic, liver, renal, metabolic, lipid, or inflammatory status.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)D80 ng/mL at any time. There were no clinically significant changes in hematologic, liver, renal, metabolic, lipid, or inflammatory status.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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text