- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Doha, Qatar, 3050
- Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: 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.
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Acute asthma exacerbations avoidable events .
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Daily symptom burden differ in slow versus rapid vitamin D deficiency correction in patients with moderate to severe asthma
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Dr.Khalid Al-Ansari, Hamad Medical Corporation
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Sykdommer i immunsystemet
- Lungesykdommer
- Overfølsomhet, Umiddelbar
- Bronkiale sykdommer
- Ernæringsforstyrrelser
- Avitaminose
- Mangelsykdommer
- Underernæring
- Lungesykdommer, obstruktiv
- Respiratorisk overfølsomhet
- Overfølsomhet
- Vitamin D-mangel
- Astma
- Fysiologiske effekter av legemidler
- Mikronæringsstoffer
- Vitaminer
- Bone Density Conservation Agents
- Vitamin d
Andre studie-ID-numre
- 1036
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