ABSTRACT
Limited research suggests that micronutrient supplementation may have a positive effect on the academic performance and behavior of school-aged children. To determine the effect of multivitamin/mineral supplementation on academic performance, students in grades three through six (approximate age range=8 to 12 years old) were recruited from 37 parochial schools in northern New Jersey to participate in a double-blind, placebo-controlled clinical trial conducted during the 2004-2005 academic school year. Participants were randomized to receive either a standard children's multivitamin/mineral supplement (MVM) or a placebo. MVM or placebo was administered in school only during lunch or snack period by a teacher or study personnel who were blinded to group assignment. The main outcome measured was change in scores on Terra Nova, a standardized achievement test administered by the State of New Jersey, at the beginning of March 2005 compared to March 2004. Compared with placebo, participants receiving MVM supplements showed no statistically significant improvement for Terra Nova National Percentile total scores by treatment assignment or for any of the subject area scores using repeated measures analysis of variance. No significant improvements were observed in secondary end points: number of days absent from school, tardiness, or grade point average. In conclusion, the in-school daily consumption of an MVM supplement by third- through sixth-grade inner-city children did not lead to improved school performance based upon standardized testing, grade point average, and absenteeism.
Subject(s)
Dietary Supplements , Educational Status , Minerals/administration & dosage , Vitamins/administration & dosage , Analysis of Variance , Child , Child Behavior/drug effects , Child Behavior/physiology , Child Nutritional Physiological Phenomena , Double-Blind Method , Female , Humans , Male , New JerseyABSTRACT
OBJECTIVES: To assess the safety, tolerance, pharmacokinetics, and virologic and immunologic changes associated with the use of Ugandan HIV hyperimmune globulin (HIVIGLOB) in HIV infected pregnant Ugandan women and their infants. DESIGN: A prospective, phase I/II, three-arm dose escalation trial of HIVIGLOB. METHODS: HIVIGLOB was prepared from discarded HIV infected units of blood collected from the National Blood Bank in Kampala. From June 1996 to April 1997, 31 HIV positive pregnant women were enrolled with HIVIGLOB infusions given at 37 weeks gestation and within 16 h of birth for infants. The first 10 mother-infant pairs were infused at a dose of 50 mg/kg, followed by 11 pairs at 200 mg/kg, and 10 pairs at 400 mg/kg. Study participants were followed for 30 months. RESULTS: Thirty-one women and 29 infants were infused with HIVIGLOB. The infusions were safe and well tolerated by the women and their infants at all doses. There were no significant changes in virologic or immunologic parameters after HIVIGLOB infusion. Pharmacokinetic properties of this product were similar to other immune globulin products with a median half-life of 28 days in women and 30 days in infants. CONCLUSION: An HIV immune globulin product derived from HIV infected Ugandan donors is safe, well tolerated, and has pharmacokinetic properties consistent with other immunoglobulin products. Data suggest that a 400 mg/kg dose of HIVIGLOB would be the most appropriate dose for a subsequent efficacy trial of HIVIGLOB for the prevention of mother to child HIV transmission.
