Document Detail


Multiple micronutrient supplementation in Tanzanian infants born to HIV-infected mothers: a randomized, double-blind, placebo-controlled clinical trial.
MedLine Citation:
PMID:  23134887     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
DESIGN: 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:
Christopher Duggan; Karim P Manji; Roland Kupka; Ronald J Bosch; Said Aboud; Rodrick Kisenge; James Okuma; Wafaie W Fawzi
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2012-11-07
Journal Detail:
Title:  The American journal of clinical nutrition     Volume:  96     ISSN:  1938-3207     ISO Abbreviation:  Am. J. Clin. Nutr.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-21     Completed Date:  2013-01-25     Revised Date:  2013-12-04    
Medline Journal Info:
Nlm Unique ID:  0376027     Medline TA:  Am J Clin Nutr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1437-46     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00197730
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MeSH Terms
Descriptor/Qualifier:
Anti-Retroviral Agents / adverse effects,  therapeutic use
Breast Feeding / adverse effects
Dietary Supplements*
Double-Blind Method
Female
Fever / prevention & control
HIV Seropositivity / drug therapy,  transmission*
Humans
Infant
Infant Mortality
Infant Nutritional Physiological Phenomena*
Infant, Newborn
Infection Control / methods*
Infectious Disease Transmission, Vertical / prevention & control*
Male
Maternal Nutritional Physiological Phenomena*
Micronutrients / administration & dosage,  therapeutic use*
Poverty Areas
Pregnancy
Pregnancy Complications, Infectious / drug therapy
Tanzania
Vomiting / prevention & control
Grant Support
ID/Acronym/Agency:
K24 HD058795/HD/NICHD NIH HHS; K24HD058795/HD/NICHD NIH HHS; R01 HD043688/HD/NICHD NIH HHS; R01 HD043688-01/HD/NICHD NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Retroviral Agents; 0/Micronutrients
Comments/Corrections

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