High-dose Vitamin A With Vaccination After 6 Months of Age: A Randomized Trial
| Autor: | Niels Danneskiold-Samsøe, Amabelia Rodrigues, Carlito Balé, Linda Hornshøj, Ane Bærent Fisker, Mathias Jul Jørgensen, Julie Rasmussen, Emil D Christensen, Bo Martin Bibby, Christine Stabell Benn, Manuel Fernandes, Ibraima Balde, Peter Aaby |
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| Rok vydání: | 2014 |
| Předmět: |
Child mortality
Male Vitamin medicine.medical_specialty Measles Vaccine Placebo law.invention chemistry.chemical_compound Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Guinea-Bissau Mortality Vitamin A Diphtheria-Tetanus-Pertussis Vaccine Vaccinations Dose-Response Relationship Drug business.industry Mortality rate Vaccination Infant Vitamin A supplementation Confidence interval Surgery chemistry Pediatrics Perinatology and Child Health Female Measles vaccine business |
| Zdroj: | Fisker, A B, Bale, C, Rodrigues, A, Balde, I, Fernandes, M, Jørgensen, M J, Danneskiold-Samsøe, N, Hornshøj, L, Rasmussen, J, Christensen, E D, Bibby, B M, Aaby, P & Benn, C S 2014, ' High-dose vitamin A with vaccination after 6 months of age : a randomized trial ', Pediatrics, vol. 134, no. 3, pp. e739-e748 . https://doi.org/10.1542/peds.2014-0550 Fisker, A B, Bale, C, Rodrigues, A, Balde, I, Fernandes, M, Jørgensen, M J, Danneskiold-Samsøe, N, Hornshøj, L, Rasmussen, J, Christensen, E D, Bibby, B M, Aaby, P & Benn, C S 2014, ' High-dose vitamin A with vaccination after 6 months of age : a randomized trial ', Pediatrics Electronic Pages, vol. 134, no. 3, pp. e739-48 . https://doi.org/10.1542/peds.2014-0550 |
| ISSN: | 1098-4275 0031-4005 |
| Popis: | BACKGROUND: The World Health Organization recommends vitamin A supplementation (VAS) at routine vaccination contacts after 6 months of age based on the assumption that it reduces mortality by 24%. The policy has never been evaluated in randomized controlled trials for its effect on overall mortality. We conducted a randomized double-blind trial to evaluate the effect of VAS with vaccines. METHODS: We randomized children aged 6 to 23 months 1:1 to VAS (100 000 IU if aged 6–11 months, 200 000 IU if aged 12–23 months) or placebo at vaccination contacts in Guinea-Bissau. Mortality rates were compared in Cox proportional-hazards models overall, and by gender and vaccine. RESULTS: Between August 2007 and November 2010, 7587 children were enrolled. Within 6 months of follow-up 80 nonaccident deaths occurred (VAS: 38; placebo: 42). The mortality rate ratio (MRR) comparing VAS versus placebo recipients was 0.91 (95% confidence interval 0.59–1.41) and differed significantly between boys (MRR 1.92 [0.98–3.75]) and girls (MRR 0.45 [0.24–0.87]) (P = .003 for interaction between VAS and gender). At enrollment, 42% (3161/7587) received live measles vaccine, 29% (2154/7587) received inactivated diphtheria-tetanus-pertussis–containing vaccines, and 21% (1610/7587) received both live and inactivated vaccines. The effect of VAS did not differ by vaccine group. CONCLUSIONS: This is the first randomized controlled trial to assess the effect of the policy on overall mortality. VAS had no overall effect, but the effect differed significantly by gender. More trials to ensure an optimal evidence-based vitamin A policy are warranted. |
| Databáze: | OpenAIRE |
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