Trial reportBMJ (Clinical research ed.)2010
Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial.
Trial report in BMJ (Clinical research ed.), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00168610 (Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries? Randomized Prospective Studies in Guinea-Bissau), which is not on this map. Cited by 49 papers, 8 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? Randomized Prospective Studies in Guinea-Bissau
Who cites it
49 citing papers in PubMed, 8 syntheses or guidelines pooled it, 104 citations in OpenAlex.
- Interventions to Prevent Post-Discharge Mortality among Children in Sub-Saharan Africa: A Systematic Review.The American journal of tropical medicine and hygiene · 2026Pooled 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
- What interventions are effective on reducing inequalities in maternal and child health in low- and middle-income settings? A systematic review.BMC public health · 2014Pooled it
- Non-specific effects of BCG and DTP vaccination on infant mortality: An analysis of birth cohorts in Ghana and Tanzania.Vaccine · 2022Trial
- Neonatal Vitamin A Supplementation and Vitamin A Status Are Associated with Gut Microbiome Composition in Bangladeshi Infants in Early Infancy and at 2 Years of Age.The Journal of nutrition · 2019Trial
- 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
- 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
- Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial.BMC pediatrics · 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
- The effect of neonatal vitamin A supplementation on growth in the first year of life among low-birth-weight infants in Guinea-Bissau: two by two factorial randomised controlled trial.BMC pediatrics · 2013Trial
Corrections and comments
- Commented on by
Authors and funding
11 authors at 5 institutions in 5 countries.
Funding
Abstract
objectiveTo investigate the effect of vitamin A supplementation and BCG vaccination at birth in low birthweight neonates.
designRandomised, placebo controlled, two by two factorial trial.
settingBissau, Guinea-Bissau.
participants1717 low birthweight neonates born at the national hospital.
interventionNeonates 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 measureMortality, 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.
resultsNo 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).
conclusionsThe 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. Trial registration ClinicalTrials.gov NCT00168610.
Indexed as
Identifiers
What OpenQuestion holds
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.