Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift

Standard

Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial. / Benn, Christine Stabell; Fisker, Ane Baerent; Napirna, Bitiguida Mutna; Roth, Adam; Diness, Birgitte Rode; Lausch, Karen Rokkedal; Ravn, Henrik; Yazdanbakhsh, Maria; Rodrigues, Amabelia; Whittle, Hilton; Aaby, Peter.

I: B M J: British Medical Journal, Vol. 340, 2010.

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift

Harvard

Benn, CS, Fisker, AB, Napirna, BM, Roth, A, Diness, BR, Lausch, KR, Ravn, H, Yazdanbakhsh, M, Rodrigues, A, Whittle, H & Aaby, P 2010, 'Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial', B M J: British Medical Journal, vol. 340. https://doi.org/10.1136/bmj.c1101

APA

CBE

MLA

Vancouver

Author

Benn, Christine Stabell ; Fisker, Ane Baerent ; Napirna, Bitiguida Mutna ; Roth, Adam ; Diness, Birgitte Rode ; Lausch, Karen Rokkedal ; Ravn, Henrik ; Yazdanbakhsh, Maria ; Rodrigues, Amabelia ; Whittle, Hilton ; Aaby, Peter. / Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial. I: B M J: British Medical Journal. 2010 ; Vol. 340.

RIS

TY - JOUR

T1 - Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial

AU - Benn, Christine Stabell

AU - Fisker, Ane Baerent

AU - Napirna, Bitiguida Mutna

AU - Roth, Adam

AU - Diness, Birgitte Rode

AU - Lausch, Karen Rokkedal

AU - Ravn, Henrik

AU - Yazdanbakhsh, Maria

AU - Rodrigues, Amabelia

AU - Whittle, Hilton

AU - Aaby, Peter

PY - 2010

Y1 - 2010

N2 - Objective To investigate the effect of vitamin A supplementation and BCG vaccination at birth in low birthweight neonates. Design Randomised, placebo controlled, two by two factorial trial. Setting Bissau, Guinea-Bissau. Participants 1717 low birthweight neonates born at the national hospital. Intervention Neonates who weighed less than 2.5 kg were randomly assigned to 25 000 IU vitamin A or placebo, as well as to early BCG vaccine or the usual late BCG vaccine, and were followed until age 12 months. Main outcome measure Mortality, calculated as mortality rate ratios (MRRs), after follow-up to 12 months of age for infants who received vitamin A supplementation compared with those who received placebo. Results No interaction was observed between vitamin A supplementation and BCG vaccine allocation (P=0.73). Vitamin A supplementation at birth was not significantly associated with mortality: the MRR of vitamin A supplementation compared with placebo, controlled for randomisation to "early BCG" versus "no early BCG" was 1.08 (95% CI 0.79 to 1.47). Stratification by sex revealed a significant interaction between vitamin A supplementation and sex (P=0.046), the MRR of vitamin A supplementation being 0.74 ( 95% CI 0.45 to 1.22) in boys and 1.42 (95% CI 0.94 to 2.15) in girls. When these data were combined with data from a complementary trial among normal birthweight neonates in Guinea-Bissau, the combined estimate of the effect of neonatal vitamin A supplementation on mortality was 1.08 ( 95% CI 0.87 to 1.33); 0.80 ( 95% CI 0.58 to 1.10) in boys and 1.41 ( 95% CI 1.04 to 1.90) in girls (P=0.01 for interaction between neonatal vitamin A and sex). Conclusions The combined results of this trial and the complementary trial among normal birthweight neonates have now shown that, overall, it would not be beneficial to implement a neonatal vitamin A supplementation policy in Guinea-Bissau. Worryingly, the trials show that vitamin A supplementation at birth can be harmful in girls. Previous studies and future trials should investigate the possibility that vitamin A supplementation has sex differential effects.

AB - Objective To investigate the effect of vitamin A supplementation and BCG vaccination at birth in low birthweight neonates. Design Randomised, placebo controlled, two by two factorial trial. Setting Bissau, Guinea-Bissau. Participants 1717 low birthweight neonates born at the national hospital. Intervention Neonates who weighed less than 2.5 kg were randomly assigned to 25 000 IU vitamin A or placebo, as well as to early BCG vaccine or the usual late BCG vaccine, and were followed until age 12 months. Main outcome measure Mortality, calculated as mortality rate ratios (MRRs), after follow-up to 12 months of age for infants who received vitamin A supplementation compared with those who received placebo. Results No interaction was observed between vitamin A supplementation and BCG vaccine allocation (P=0.73). Vitamin A supplementation at birth was not significantly associated with mortality: the MRR of vitamin A supplementation compared with placebo, controlled for randomisation to "early BCG" versus "no early BCG" was 1.08 (95% CI 0.79 to 1.47). Stratification by sex revealed a significant interaction between vitamin A supplementation and sex (P=0.046), the MRR of vitamin A supplementation being 0.74 ( 95% CI 0.45 to 1.22) in boys and 1.42 (95% CI 0.94 to 2.15) in girls. When these data were combined with data from a complementary trial among normal birthweight neonates in Guinea-Bissau, the combined estimate of the effect of neonatal vitamin A supplementation on mortality was 1.08 ( 95% CI 0.87 to 1.33); 0.80 ( 95% CI 0.58 to 1.10) in boys and 1.41 ( 95% CI 1.04 to 1.90) in girls (P=0.01 for interaction between neonatal vitamin A and sex). Conclusions The combined results of this trial and the complementary trial among normal birthweight neonates have now shown that, overall, it would not be beneficial to implement a neonatal vitamin A supplementation policy in Guinea-Bissau. Worryingly, the trials show that vitamin A supplementation at birth can be harmful in girls. Previous studies and future trials should investigate the possibility that vitamin A supplementation has sex differential effects.

U2 - 10.1136/bmj.c1101

DO - 10.1136/bmj.c1101

M3 - Article

VL - 340

JO - B M J: British Medical Journal

JF - B M J: British Medical Journal

SN - 1756-1833

ER -