Circulating 25-Hydroxyvitamin D Levels in Fully Breastfed Infants on Oral Vitamin D Supplementation

Objective. To examine the effectiveness of oral vitamin D3 (400 IU) supplementation on the nutritional vitamin D status of breastfeeding infants. Design. As part of a larger ongoing vitamin D RCT trial of lactating women, infants of mothers assigned to control received 1 drop of 400 IU vitamin D3/day starting at one month of age. Infant 25(OH)D levels (mean ± S.D.) were measured by RIA at visits 1, 4, and 7. Results. The infant mean ± S.D. 25(OH)D at baseline was 16.0 ±9.3 ng/mL (range 1.0–40.8; n = 33); 24 (72.7%) had baseline levels <20 ng/mL (consistent with deficiency). The mean levels increased to 43.6 ±14.1 (range 18.2–69.7) at 4 months and remained relatively unchanged at month 7: 42.5 ±12.1 ng/mL (range 18.9–67.2). The change in values between 1 and 4 months and 1 and 7 months was statistically significant (P ≤ .0001), and despite a decrease in dose per kilogram, values were not significantly different between months 4 and 7 (P = .66). Conclusions. Oral vitamin D3 supplementation as an oil emulsion was associated with significant and sustained increases in 25(OH)D from baseline in fully breastfeeding infants through 7 months

The safety of self-administered allergen immunotherapy during the buildup and maintenance phases

Background—Self-administered allergen immunotherapy is considered controversial. We believe the implementation of a self-administration protocol characterized by patient preselection and a slow buildup phase is safe. Methods—We analyzed 23,614 patient records and associated immunotherapy injections for systemic reactions (SR) during a 1-year period (2011 to 2012). SRs were graded in accordance with the World Allergy Organization (WAO) criteria. Results—Thirty-seven SRs were reported for 23,614 patients who self-administered 2,021,600 injections yielding an annual SR rate of 0.16% (per patient) or 0.002% (per injection). Only 9 of 4643 pediatric (0.19%) and 28 of 18,971 adult patients (0.15%) experienced 1 or more SRs. No deaths (grade V SR) occurred. From 2009 through early 2014, over 90,000 patients received more than 10 million injections in accordance with the United Allergy Services (UAS) protocol without fatalities. Conclusion—We believe this safety profile is due to a preselection of patients to exclude those with a high risk for adverse reactions and a slow immunotherapy buildup phase. In contrast, previous studies documented office-based SRs ranging from approximately 3% to greater than 14%. Thus, the UAS home-immunotherapy SR rate is significantly lower than office-based immunotherapy SR rates (p \u3c 0.0001). The enhanced safety of this protocol results in a decreased frequency and severity of SRs. This safety report, derived from analyses of one of the largest patient cohorts studied, corroborates and expands the observations of previous studies of selfadministered subcutaneous immunotherapy in a low-risk patient population by assessing selfadministered allergen immunotherapy during the buildup and maintenance phases

Indications for Use of Combination Acetaminophen/Opioid Drugs in Infants \u3c6 Months Old

Opioid analgesics are potentially hazardous medications in young children. During the past 5 years, much attention has been drawn to the safety concerns of these medications.1–6 Data evaluating pain control after injury among older children suggest that opioid drugs are not more effective than nonopioids in treating pain secondary to acute traumatic injury.7,8 Postsurgical data evaluating children who underwent palatoplasty demonstrated that children treated with nonopioid pain regimens did as well as subjects treated with morphine.9 More concerning, opioid analgesics have been consistently demonstrated to be among the most common drugs involved in accidental ingestions prompting emergency department visits and rank consistently high as contributors to medication-related death in children.1 Data from nonopioid medication studies have demonstrated that young children, particularly infants, are at higher risk for experiencing drug errors and experiencing adverse outcomes should they experience a dosing error.10 In previous studies, we demonstrated that children 0 to 36 months old who received opioid drugs received a potential overdose approximately 1.6% to 2.7% of the time, and the frequency of potential opioid overdose may be as high as 11.8% among children 0 to 2 months old.11,12 In this brief report, we examined South Carolina Medicaid data to determine the indications for receipt of opioid analgesics among subjects 0 to old

Bioequivalence Studies of Vitamin D Gummies and Tablets in Healthy Adults: Results of a Cross-Over Study

The objective of this investigation was to compare bioavailability between single oral dose Vitamin D3 (vitD3) gummies vs. tablets in healthy adults. An initial crossover, randomized clinical trial involving healthy adults (n = 9) was conducted followed by a larger, confirmatory study (n = 31). Healthy participants aged 18&#8722;45 years with body mass index (BMI) 18&#8722;30 without anemia or vitD deficiency were randomized to receive 20,000 international units (IU) vitD3 as single dose gummies or tablets with serial samples obtained to measure plasma vitD3 at baseline, 3, 6, 10, 24, and 48 h followed by a 2-week washout period. The same participants then crossed over to receive 20,000 IU vitD3 in the form not previously given, with sampling at the same time points. Deidentified blood samples were analyzed for vitD3 concentration by liquid chromatography (LC)-mass spectroscopy. In Study 1, results suggested bioavailability was greater with gummies compared with tablets, (effect size 1.08 at 24 h). In Study 2, the area under the concentration curve (AUC) was higher with gummies than tablets (gummy mean (95% CI): 1474 ng&#183;/mL (1393&#8722;1555); tablet mean (95% CI): 774 ng&#183;h/mL (693&#8722;855), p &lt; 0.0001). Average peak blood concentration (Cmax) values were significantly higher with gummies (gummy: 47.3 ng/mL; tablet: 23.4 ng/mL; p &lt; 0.0001). VitD3 gummies had greater bioavailability than tablets with higher vitD concentrations over time, which may have implications for achieving vitD sufficiency

A Retrospective Database Analysis of Neonatal Morbidities to Evaluate a Composite Endpoint for Use in Preterm Labor Clinical Trials

Objective  To propose and assess a composite endpoint (CE) of neonatal benefit based on neonatal mortality and morbidities by gestational age (GA) for use in preterm labor clinical trials. Study Design  A descriptive, retrospective analysis of the Medical University of South Carolina Perinatal Information System database was conducted. Neonatal morbidities were assessed for inclusion in the CE based on clinical significance/risk of childhood neurodevelopmental impairment, frequency, and association with GA in a mother–neonate linked cohort, comprising women with uncomplicated singleton pregnancies delivered at ≥24 weeks\u27 GA. Results  Among 17,912 mother–neonate pairs, neonates were at a risk of numerous severe but infrequent morbidities. Clinically important, predominantly rare events were combined into a CE comprising neonatal mortality and morbidities, which decreased in frequency with increasing GA. The highest CE frequency occurred at syndrome, bronchopulmonary dysplasia, and sepsis drove the CE. Median length of hospital stay was longer at all GAs in those with the CE compared with those without. Conclusions  Descriptive epidemiological assessment and clinical input were used to develop a CE to measure neonatal benefit, comprising clinically meaningful outcomes. These empirical data and CE allowed trials investigating tocolytics to be sized appropriately