- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Doha, Qatar, 3050
- Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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.
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Comparateur actif: Oral-only 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Acute asthma exacerbations avoidable events .
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Daily symptom burden differ in slow versus rapid vitamin D deficiency correction in patients with moderate to severe asthma
Délai: 12 month
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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
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Dr.Khalid Al-Ansari, Hamad Medical Corporation
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies du système immunitaire
- Maladies pulmonaires
- Hypersensibilité immédiate
- Maladies bronchiques
- Troubles nutritionnels
- Avitaminose
- Maladies de carence
- Malnutrition
- Maladies pulmonaires obstructives
- Hypersensibilité respiratoire
- Hypersensibilité
- Carence en vitamine D
- Asthme
- Effets physiologiques des médicaments
- Micronutriments
- Vitamines
- Agents de conservation de la densité osseuse
- Vitamine D
Autres numéros d'identification d'étude
- 1036
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Essais cliniques sur Vitamin D
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Johnson & Johnson Consumer Inc. (J&JCI)Complété
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Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)ComplétéAnémie de la maladie rénale chroniqueÉtats-Unis