title: Multiple micronutrient supplementation in Tanzanian infants born to HIV-infected mothers: a randomized, double-blind, placebo-controlled clinical trial.
abstract: BACKGROUND
  Multiple micronutrients (vitamin B complex and vitamins C and E) were effective at reducing infectious disease morbidity, HIV disease progression, and poor pregnancy outcomes in HIV-infected women.
  
  
  OBJECTIVE
  The objective was to evaluate whether direct supplementation of these micronutrients to HIV-exposed infants reduces mortality and morbidity.
  
  
  METHODS
  Infants born to HIV-infected women from Dar es Salaam, Tanzania, were randomly assigned to receive daily oral supplementation of multiple multivitamins (vitamin B complex and vitamins C and E) or placebo from age 6 wk for 24 mo. All-cause mortality, hospitalizations, and unscheduled clinic visits were recorded. Morbidities were recorded during monthly follow-up visits. All mothers received multiple micronutrients throughout the study.
  
  
  RESULTS
  A total of 1193 infants were randomly assigned to receive micronutrients and 1194 to receive placebo. There were 138 child deaths in the multivitamin group and 124 deaths in the placebo group (HR: 1.13; 95% CI: 0.88, 1.44; P = 0.33). Hospitalizations (RR: 0.83; 95% CI: 0.62, 1.13; P = 0.23), unscheduled clinic visits (RR: 0.97; 95% CI: 0.85, 1.10; P = 0.59), and maternal reports of diarrhea (RR: 0.97; 0.87, 1.10; P = 0.64) were not significantly different between the 2 groups. Fever (P = 0.02) and vomiting (P = 0.007) were significantly lower in the multivitamin group. Among 429 children whose mothers received antiretroviral (ARV) therapy, multivitamin use had no effect on mortality but was associated with a significant reduction in hospitalizations (P = 0.035), episodes of fever (P = 0.005), and episodes of fever and cough (P = 0.019).
  
  
  CONCLUSIONS
  In the setting of maternal micronutrient supplementation, supplementation of HIV-exposed infants with vitamin B and vitamins C and E does not reduce mortality. Studies of nutrition supplementation in ARV-exposed infants may be warranted.
authors.affiliation: Department of Nutrition, Harvard School of Public Health, Boston, MA, USA. christopher.duggan@childrens.harvard.edu
authors.forename: Christopher
authors.initials: C
authors.lastname: Duggan
authors.forename: Karim P
authors.initials: KP
authors.lastname: Manji
authors.forename: Roland
authors.initials: R
authors.lastname: Kupka
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Bosch
authors.forename: Said
authors.initials: S
authors.lastname: Aboud
authors.forename: Rodrick
authors.initials: R
authors.lastname: Kisenge
authors.forename: James
authors.initials: J
authors.lastname: Okuma
authors.forename: Wafaie W
authors.initials: WW
authors.lastname: Fawzi
mesh_terms: D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use; D001942:Breast Feeding / Q000009:adverse effects; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000517:prevention & control; D006679:HIV Seropositivity / Q000188:drug therapy / Q000635:transmission*; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D017053:Infection Control / Q000379:methods*; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D039382:Maternal Nutritional Physiological Phenomena; D018977:Micronutrients / Q000008:administration & dosage / Q000627:therapeutic use*; D011204:Poverty Areas; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D013636:Tanzania; D014839:Vomiting / Q000517:prevention & control
chemical_list: D044966:Anti-Retroviral Agents; D018977:Micronutrients