The effect of high-dose vitamin A supplementation given with bacille Calmette-Guérin vaccine at birth on infant rotavirus infection and diarrhea: a randomized prospective study from Guinea-Bissau.
BACKGROUND
Prophylactic vitamin A supplementation (VAS) reduces mortality and may reduce morbidity associated with diarrhea in children >6 months of age. Rotavirus is the most common cause of acute dehydrating diarrhea among children worldwide.


METHODS
In a randomized placebo-controlled study of 50,000 IU of vitamin A versus placebo given with bacille Calmette-Guérin vaccine at birth, 287 infants were followed up with weekly interviews and stool sample obtainment to test the hypothesis that VAS reduced the risk of rotavirus infection.


RESULTS
VAS was associated with increased risk of rotavirus infection and diarrhea (incidence rate ratio [IRR] of infection, 1.72 [95% confidence interval (CI), 1.04-2.85]; IRR of diarrhea, 3.74 [95% CI, 1.40-9.98]) among children <6 months of age. There was no effect in older children. VAS had a beneficial effect on nonrotavirus diarrhea in boys <6 months of age (IRR, 0.51; 95% CI, 0.27-0.95) and a detrimental effect in girls >6 months of age (IRR, 1.84; 95% CI, 0.96-3.55).


CONCLUSIONS
VAS at birth did not reduce rotavirus morbidity. The effect of VAS on nonrotavirus diarrhea may differ by sex, being more beneficial in boys. Clinical trials registration. NCT00168597 .
Diness
Birgitte Rode
BR
Bandim Health Project, INDEPTH Network, Guinea-Bissau. Birgitte@Diness.dk
Christoffersen
Dorthe
D
Pedersen
Ulla Britt
UB
Rodrigues
Amabelia
A
Fischer
Thea Kølsen
TK
Andersen
Andreas
A
Whittle
Hilton
H
Yazdanbakhsh
Maria
M
Aaby
Peter
P
Benn
Christine Stabell
CS
D000367:Age Factors; D001500:BCG Vaccine / Q000008:administration & dosage*; D003967:Diarrhea / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D004196:Disease Outbreaks / Q000517:prevention & control; D005260:Female; D006169:Guinea-Bissau / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D012400:Rotavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D012737:Sex Factors; D014801:Vitamin A / Q000008:administration & dosage / Q000627:therapeutic use*; D014815:Vitamins / Q000008:administration & dosage / Q000627:therapeutic use*
D001500:BCG Vaccine; D014815:Vitamins; D014801:Vitamin A