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Ensayo controlado aleatorizado2012Acceso abierto

Effect on the incidence of pneumonia of vitamin D supplementation by quarterly bolus dose to infants in Kabul: a randomised controlled superiority trial

Manaseki-Holland S, Maroof Z, Bruce J, Mughal MZ, Masher MI, Bhutta ZA, Walraven G, Chandramohan D

Lancet (London, England) · 150 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Eventos clínicos como enfermedad o muerte

Quién lo pagó

Financiación
Financiación independiente
Gobierno
United States Agency for International Development
Organización sin fines de lucro
Wellcome Trust

Según 2 financiadores declarados y la declaración de financiación del texto completo.

Publicación

Publicado
2012-04-01 · Lancet · vol. 379 · número 9824 · págs. 1419–1427
Editorial
Elsevier BV
Citado
207 citas · más que el 99% de estudios similares · 13.7× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
38 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Vitamin D Research Studies · Pneumonia and Respiratory Infections · Child Nutrition and Water Access
Palabras clave
vitamin D supplementation, vitamin D3, pediatric pneumonia, infant health, pneumonia incidence, vitamin D deficiency, vitamin D toxicity, Kabul
MeSH
humans, pneumonia, vitamin d, treatment outcome, drug administration schedule, pulse therapy, drug, incidence, confidence intervals, risk assessment, follow-up studies, dose-response relationship, drug, reference values, developing countries, dietary supplements, infant, infant, newborn, afghanistan, female, male

8 autores

  • Semira Manaseki‐Holland🇬🇧University of Birmingham
  • Zabihullah Maroof🇬🇧London School of Hygiene & Tropical Medicine
  • Jane Bruce🇬🇧London School of Hygiene & Tropical Medicine
  • Zulf Mughal🇵🇰🇦🇫🇬🇧Aga Khan University; Kabul University of Medical Sciences Abu Ali Ibn Sina; Royal Manchester Children's Hospital
  • Mohammad Isaq Masher🇦🇫Kabul University of Medical Sciences Abu Ali Ibn Sina
  • Zulfiqar Ahmed Bhutta🇵🇰Aga Khan University
  • Gijs E. L. Walraven🇵🇰Aga Khan Development Network
  • Daniel Chandramohan🇬🇧London School of Hygiene & Tropical Medicine

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

Vitamin D has a role in regulating immune function, and its deficiency is a suggested risk factor for childhood pneumonia. Our aim was to assess whether oral supplementation of vitamin D(3) (cholecalciferol) will reduce the incidence and severity of pneumonia in a high-risk infant population.

Methods

We did a randomised placebo-controlled trial to compare oral 100,000 IU (2·5 mg) vitamin D(3) with placebo given to children aged 1-11 months in Kabul, Afghanistan. Randomisation was by use of a computer-generated list. Vitamin D or placebo was given by fieldworkers once every 3 months for 18 months. Children presenting at the study hospital with signs of pneumonia had their diagnosis confirmed radiographically. Our primary outcome was the first or only episode of radiologically confirmed pneumonia. Our analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00548379.

Findings

1524 children were assigned to receive vitamin D(3) and 1522 placebo. There was no significant difference between the incidence of first or only pneumonia between the vitamin D (0·145 per child per year, 95% CI 0·129-0·164) and the placebo group (0.137, 0·121-0·155); the incidence rate ratio was 1·06 (95% CI 0·89-1·27). From 652 children during five separate periods of testing serum calcifediol, only one child in each of two testing periods had results greater than 375 nmol/L in the intervention group--a toxic level.

Interpretations

Quarterly bolus doses of oral vitamin D(3) supplementation to infants are not an effective intervention to reduce the incidence of pneumonia in infants in this setting.

Funding

Wellcome Trust and British Council.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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