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- Ensayo clínico NCT01395589
Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations.
Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Recently published Cochrane metaanalysis suggested that vitamin D reduces the risk of severe asthma exacerbations, but only 22 children contributed to that analysis from a study that found no difference in acute care visits or rescue steroid administration. Altogether, randomized trials performed in children show promise solely in meta-analyses that use varied clinical outcomes and analysis approaches.
Were vitamin D supplementation beneficial for children with asthma, it might prevent moderate to severe asthma exacerbations entirely in some children, reduce the overall frequency of exacerbations in a treated group, or both. To examine these possibilities, we designed a randomized explanatory study comparing rapid vs maintenance vitamin D supplementation for children with moderate-to-severe asthma and with low baseline vitamin D levels .
Children presenting to the ED with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months.The primary outcome was patient-initiated unplanned visits for asthma exacerbations,examined two ways: cumulative proportions with an exacerbation, and average exacerbation frequency. As this was a nutrient study, we analyzed treatment groups by quartile of baseline vitamin D level, collecting repeat levels and clinical observations at 3, 6, 9,and 12 months after enrollment.
One hundred and sixteen patients in the IM+oral cohort vs 115 in the oral-only cohort had similar mean (SD) baseline levels: 15.1 (5.4) vs 15.8 (5.2) ng/mL (range, 3-25 ng/mL). There was no difference in the primary outcome over the entire 12-month observation period. However, rapid IM+oral supplementation significantly reduced unplanned visits for asthma exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months: the relative exacerbation rate for the IM+oral cohort compared with the oral-only cohort at 3 months was 0.48 (95% CI, 0.28-0.89; P ¼ .008); average exacerbation frequency per child analysis, relative rate 0.36 (95% CI, 0.13-0.87; P ¼ .017).
So Rapid compared to maintenance vitamin D supplementation for children with the lowest levels resulted in short- but not long-term reduction in asthma exacerbations.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Doha, Katar, 3050
- Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Children 2-14 years of age with moderate to severe asthma and proved to be Vitamin D deficient by serum level.
EXCLUSION CRITERIA:
- Prematurity (Gestational age 34 weeks or less)
- Patients on vitamin D therapy
- Patients on seizure medication or diuretics
- Patients on chronic steroid use for other reasons than asthma
- Patient with chronic liver or kidney disease
- Patients with inherited bone disease
- Patients with hypo or hyper parathyroidism
- Patients with history of chronic lung disease other than asthma
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Injectable + oral vitamin D
Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.
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Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months.
|
Comparador activo: Oral-only Vitamin D
Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.
|
Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Acute asthma exacerbations avoidable events .
Periodo de tiempo: 12 month
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Rapid compared to maintenance oral supplementation with vitamin D significantly reduced unplanned visits for asthma exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months of treatment but not thereafter.
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12 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Daily symptom burden differ in slow versus rapid vitamin D deficiency correction in patients with moderate to severe asthma
Periodo de tiempo: 12 month
|
Rapid compared to maintenance vitamin D supplementation for children with the lowest levels resulted in short- but not long-term reduction in asthma exacerbations.
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12 month
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Dr.Khalid Al-Ansari, Hamad Medical Corporation
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades del sistema inmunológico
- Enfermedades pulmonares
- Hipersensibilidad, Inmediata
- Enfermedades bronquiales
- Trastornos Nutricionales
- Avitaminosis
- Enfermedades por deficiencia
- Desnutrición
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad
- Deficiencia de vitamina D
- Asma
- Efectos fisiológicos de las drogas
- Micronutrientes
- Vitaminas
- Agentes de conservación de la densidad ósea
- Vitamina D
Otros números de identificación del estudio
- 1036
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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