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Vitamin D Deficiency and Asthma Exacerbation (AVD)

18. januar 2016 opdateret af: Caterina Bucca, University of Turin, Italy

Effect of Vitamin D Repletion on Asthma Exacerbation

The study aim is in two phases. First phase: to evaluate the influence of vitamin D deficiency on asthma severity, degree of airway obstruction and frequency of asthma exacerbations. Second phase: to evaluate if in patients with vitamin D deficiency (25-OH vitamin D levels below 20 ng/ml), vitamin D supplementation decreases the number of disease exacerbations.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The first phase of the study consisted of a cross-sectional examination of a cohort of 119 asthmatic patients, who had at least one year regular follow-up in our respiratory clinic, and were not receiving any vitamin D supplementation.

In the second phase patients with vitamin D deficiency (25-OH D values below 20 ng/ml), were recruited in a one year longitudinal study, during which they received vitamin D supplementation. The study started and ended in late autumn-winter season when, at our latitude, sun exposure is lowest. Symptoms, spirometry and number of exacerbations were recorded during both study phases.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

119

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 80 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • All the consecutive patients with bronchial asthma of any severity, who presented for a scheduled visit at our Respiratory Clinic during the period October 2012-March 2013 and who had at least one year regular follow-up every three months

Exclusion Criteria:

  • Acute exacerbation in the last month and treatment with vitamins and dietary supplements in the last year.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: asthma severity and disease exacerbation
intramuscular cholecalciferol 100,000 IU, followed by oral cholecalciferol 5000 IU weekly plus 400 IU daily for one year
Medicin: oral cholecalciferol
Inhaled corticosteroids and long-acting beta-agonists, salbutamol
Andre navne:
  • intramuscular cholecalciferol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relationship between serum 25-hydroxide (OH) vitamin D level and asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
Tidsramme: one year
119 consecutive asthmatic patients underwent serum vitamin D (25-OHD) and lung function assessment. Their medical records were retrospectively reviewed, to gain information on disease exacerbations during the 12 months preceding study entry. The relationship between baseline 25-OH vitamin D and number of exacerbation was investigated
one year
Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
Tidsramme: One year
55 asthmatic patients with 25-OH vitamin D below 20 ng/ml underwent supplementation with cholecalciferol for one year (intramuscular 100,000 IU, followed by oral 5000 IU weekly plus 400 IU daily for one year). Number of exacerbations were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency
One year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relationship between serum 25-OH vitamin D level and airway obstruction (evaluated by spirometry: one second forced expiratory volume, FEV1 l/sec, vital capacity (VC) and FEV1/VC%)
Tidsramme: one year
119 consecutive asthmatic patients underwent serum vitamin D (25-OHD, ng/ml) and lung function assessment. Their medical records were retrospectively reviewed, to gain information on lung function tests (forced expiratory volume in 1 second, FEV1, and vital capacity, VC) during the 12 months preceding study entry. The relationship between baseline 25-OH vitamin D and airway obstruction (FEV1 and FEV1/VC%) was investigated
one year
Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on airway obstruction ( FEV1 l/sec, FEV1/VC%)
Tidsramme: one year
55 asthmatic patients with 25-OH vitamin D below 20 ng/ml underwent supplementation with cholecalciferol for one year (intramuscular 100,000 IU, followed by oral 5000 IU weekly plus 400 IU daily for one year). Lung function tests (FEV1, VC and FEV1/VC%) were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency
one year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Turin, Italy

Efterforskere

  • Studiestol: Caterina B Bucca, MD, Dept. Medical Science, University of Turin

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

21. december 2015

Først indsendt, der opfyldte QC-kriterier

18. januar 2016

Først opslået (Skøn)

22. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ASTHMAVITD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med D-vitamin mangel

Kliniske forsøg med oral cholecalciferol

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Placeringer

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