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Effect of 50 000 IU vitamin A given with BCG vaccine on mortality in infants in Guinea-Bissau: randomised placebo controlled trial

Benn, Christine Stabell; Diness, Birgitte Rode; Roth, Adam LU ; Nante, Ernesto; Fisker, Ane Baerent; Lisse, Ida Maria; Yazdanbakhsh, Maria; Whittle, Hilton; Rodrigues, Amabelia and Aaby, Peter (2008) In BMJ (International Edition)1988-01-01+01:002008-01-01+01:00 336(7658). p.1416-1416
Abstract
Objective To investigate the effect of high dose vitamin A supplementation given with BCG vaccine at birth in an African setting with high infant mortality. Design Randomised placebo controlled trial. Setting Bandim Health Project's demographic surveillance system in Guinea-Bissau, covering approximately 90 000 inhabitants. Participants 4345 infants due to receive BCG. Intervention Infants were randomised to 50 000 IU vitamin A or placebo and followed until age 12 months. Main outcome measure Mortality rate ratios. Results 174 children died during follow-up (mortality=47/ 1000 person-years). Vitamin A supplementation was not significantly associated with mortality; the mortality rate ratio was 1.07 (95% confidence interval 0.79 to 1.44).... (More)
Objective To investigate the effect of high dose vitamin A supplementation given with BCG vaccine at birth in an African setting with high infant mortality. Design Randomised placebo controlled trial. Setting Bandim Health Project's demographic surveillance system in Guinea-Bissau, covering approximately 90 000 inhabitants. Participants 4345 infants due to receive BCG. Intervention Infants were randomised to 50 000 IU vitamin A or placebo and followed until age 12 months. Main outcome measure Mortality rate ratios. Results 174 children died during follow-up (mortality=47/ 1000 person-years). Vitamin A supplementation was not significantly associated with mortality; the mortality rate ratio was 1.07 (95% confidence interval 0.79 to 1.44). The effect was 1.00 (0.65 to 1.56) during the first four months and 1.13 (0.75 to 1.68) from 4 to 12 months of age. The mortality rate ratio in boys was 0.84 (0.55 to 1.27) compared with 1.39 (0.90 to 2.14) in girls (P for interaction=0.10). An explorative analysis revealed a strong interaction between vitamin A and season of administration. Conclusions Vitamin A supplementation given with BCG vaccine at birth had no significant benefit in this African setting. Although little doubt exists that vitamin A supplementation reduces mortality in older children, a global recommendation of supplementation for all newborn infants may not contribute to better survival. Registration Clinical trials NCT00168597. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
BMJ (International Edition)1988-01-01+01:002008-01-01+01:00
volume
336
issue
7658
pages
1416 - 1416
publisher
BMJ Publishing Group
external identifiers
  • wos:000257123200032
  • scopus:46749121528
ISSN
0959-8146
DOI
10.1136/bmj.39542.509444.AE
language
English
LU publication?
yes
id
18733ef2-e142-41ad-859b-93653b6c6bdc (old id 1191161)
date added to LUP
2008-09-08 11:50:42
date last changed
2017-10-22 03:58:25
@article{18733ef2-e142-41ad-859b-93653b6c6bdc,
  abstract     = {Objective To investigate the effect of high dose vitamin A supplementation given with BCG vaccine at birth in an African setting with high infant mortality. Design Randomised placebo controlled trial. Setting Bandim Health Project's demographic surveillance system in Guinea-Bissau, covering approximately 90 000 inhabitants. Participants 4345 infants due to receive BCG. Intervention Infants were randomised to 50 000 IU vitamin A or placebo and followed until age 12 months. Main outcome measure Mortality rate ratios. Results 174 children died during follow-up (mortality=47/ 1000 person-years). Vitamin A supplementation was not significantly associated with mortality; the mortality rate ratio was 1.07 (95% confidence interval 0.79 to 1.44). The effect was 1.00 (0.65 to 1.56) during the first four months and 1.13 (0.75 to 1.68) from 4 to 12 months of age. The mortality rate ratio in boys was 0.84 (0.55 to 1.27) compared with 1.39 (0.90 to 2.14) in girls (P for interaction=0.10). An explorative analysis revealed a strong interaction between vitamin A and season of administration. Conclusions Vitamin A supplementation given with BCG vaccine at birth had no significant benefit in this African setting. Although little doubt exists that vitamin A supplementation reduces mortality in older children, a global recommendation of supplementation for all newborn infants may not contribute to better survival. Registration Clinical trials NCT00168597.},
  author       = {Benn, Christine Stabell and Diness, Birgitte Rode and Roth, Adam and Nante, Ernesto and Fisker, Ane Baerent and Lisse, Ida Maria and Yazdanbakhsh, Maria and Whittle, Hilton and Rodrigues, Amabelia and Aaby, Peter},
  issn         = {0959-8146},
  language     = {eng},
  number       = {7658},
  pages        = {1416--1416},
  publisher    = {BMJ Publishing Group},
  series       = {	BMJ (International Edition)1988-01-01+01:002008-01-01+01:00},
  title        = {Effect of 50 000 IU vitamin A given with BCG vaccine on mortality in infants in Guinea-Bissau: randomised placebo controlled trial},
  url          = {http://dx.doi.org/10.1136/bmj.39542.509444.AE},
  volume       = {336},
  year         = {2008},
}