Trial reportBMJ (Clinical research ed.)2008
Effect of 50,000 IU vitamin A given with BCG vaccine on mortality in infants in Guinea-Bissau: randomised placebo controlled trial.
Trial report in BMJ (Clinical research ed.), 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00168597 (Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries?), which is not on this map. Cited by 53 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries?
Who cites it
53 citing papers in PubMed, 9 syntheses or guidelines pooled it, 119 citations in OpenAlex.
- Pooled it
- Pooled it
- Metabolism of Neonatal Vitamin A Supplementation: A Systematic Review.Advances in nutrition (Bethesda, Md.) · 2021Pooled it
- Pooled it
- Early neonatal vitamin A supplementation and infant mortality: an individual participant data meta-analysis of randomised controlled trials.Archives of disease in childhood · 2019Pooled it
- Neonatal vitamin A supplementation for the prevention of mortality and morbidity in term neonates in low and middle income countries.The Cochrane database of systematic reviews · 2017Pooled it
- Is diphtheria-tetanus-pertussis (DTP) associated with increased female mortality? A meta-analysis testing the hypotheses of sex-differential non-specific effects of DTP vaccine.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2016Pooled it
- Impact of vitamin A supplementation on infant and childhood mortality.BMC public health · 2011Pooled it
- Vitamin A supplementation and neonatal mortality in the developing world: a meta-regression of cluster-randomized trials.Bulletin of the World Health Organization · 2010Pooled it
- High-Dose Neonatal Vitamin A Supplementation Transiently Decreases Thymic Function in Early Infancy.The Journal of nutrition · 2020Trial
- Early BCG-Denmark and Neonatal Mortality Among Infants Weighing <2500 g: A Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017Trial
- Trial
- Trial
- The effect of early measles vaccination at 4.5 months of age on growth at 9 and 24 months of age in a randomized trial in Guinea-Bissau.BMC pediatrics · 2016Trial
- The effect of neonatal vitamin A supplementation on morbidity and mortality at 12 months: a randomized trial.International journal of epidemiology · 2016Trial
- The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015Trial
- Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial.Lancet (London, England) · 2015Trial
- Trial
- Trial
- A randomized trial of a standard dose of Edmonston-Zagreb measles vaccine given at 4.5 months of age: effect on total hospital admissions.The Journal of infectious diseases · 2014Trial
Corrections and comments
- Commented on by
Authors and funding
10 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo investigate the effect of high dose vitamin A supplementation given with BCG vaccine at birth in an African setting with high infant mortality.
designRandomised 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.
interventionInfants were randomised to 50,000 IU vitamin A or placebo and followed until age 12 months.
main outcome measureMortality rate ratios.
results174 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.
conclusionsVitamin 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.
trial registrationClinical trials NCT00168597.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.