OBJECTIVE: To test the efficacy of a high dose of vitamin A as adjuvant treatment for radiographically confirmed cases of acute lower respiratory tract infection (ALRI). DESIGN: Randomized, double-masked, placebo-controlled clinical trial. SETTING:Two large urban hospitals in Guatemala City. PATIENTS: Sequential sample of 263 children aged 3 to 48 months, identified in the emergency departments and admitted to the hospital. INTERVENTIONS:Vitamin A (100,000 IU for children less than 1 year of age, and 200,000 IU for older children) or placebo in addition to standard treatment for ALRI which included antibiotics, oxygen, bronchodilators, and intravenously administered solutions. MEASUREMENTS AND MAIN RESULTS: The children were assessed every 8 hours. There were neither statistically nor clinically significant differences by treatment group in the rate of normalization in respiratory rate, oxygen saturation, temperature, or clinical score. Duration of hospitalization was not different by treatment group. Adverse outcomes (mechanical ventilation, prolonged hospitalization, readmission or transfer, and death) were equally distributed between the two groups. CONCLUSIONS: Treatment with high doses of vitamin A over and above standard care for infants and children with non-measles-related ALRI is not efficacious for the current episode. Additional trials among populations in which vitamin A deficiency is more prevalent and severe should be considered.
RCT Entities:
OBJECTIVE: To test the efficacy of a high dose of vitamin A as adjuvant treatment for radiographically confirmed cases of acute lower respiratory tract infection (ALRI). DESIGN: Randomized, double-masked, placebo-controlled clinical trial. SETTING: Two large urban hospitals in Guatemala City. PATIENTS: Sequential sample of 263 children aged 3 to 48 months, identified in the emergency departments and admitted to the hospital. INTERVENTIONS:Vitamin A (100,000 IU for children less than 1 year of age, and 200,000 IU for older children) or placebo in addition to standard treatment for ALRI which included antibiotics, oxygen, bronchodilators, and intravenously administered solutions. MEASUREMENTS AND MAIN RESULTS: The children were assessed every 8 hours. There were neither statistically nor clinically significant differences by treatment group in the rate of normalization in respiratory rate, oxygen saturation, temperature, or clinical score. Duration of hospitalization was not different by treatment group. Adverse outcomes (mechanical ventilation, prolonged hospitalization, readmission or transfer, and death) were equally distributed between the two groups. CONCLUSIONS: Treatment with high doses of vitamin A over and above standard care for infants and children with non-measles-related ALRI is not efficacious for the current episode. Additional trials among populations in which vitamin A deficiency is more prevalent and severe should be considered.
Entities:
Keywords:
Age Factors; Americas; Biology; Central America; Child; Demographic Factors; Developing Countries; Diseases; Double-blind Studies; Guatemala; Infant; Infections; Latin America; North America; Physiology; Population; Population Characteristics; Research Methodology; Respiratory Infections; Studies; Treatment; Vitamin A--administraction and dosage; Vitamins; Youth
Authors: Evropi Theodoratou; Sarah Al-Jilaihawi; Felicity Woodward; Joy Ferguson; Arnoupe Jhass; Manuela Balliet; Ivana Kolcic; Salim Sadruddin; Trevor Duke; Igor Rudan; Harry Campbell Journal: Int J Epidemiol Date: 2010-04 Impact factor: 7.196
Authors: Anastasia N Vlasova; Kuldeep S Chattha; Sukumar Kandasamy; Christine S Siegismund; Linda J Saif Journal: J Immunol Date: 2013-03-27 Impact factor: 5.422