A randomised controlled trial to test whether active vitamin D can improve the clinical response to steroids in asthmatic patients

Completed

• Conditions: Asthma; Respiratory

• Registration Number: ISRCTN29378424
• Lead Sponsor: King?s College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Male or female adults aged between 18 to 65 years
2. Documented history and typical symptoms of asthma for greater than or equal to 6 months prior to screening
3. Pre-bronchodilator forced expriatory volume in one second (FEV1) less than 70% predicted and greater than 15% reversibility to beta 2-agonist or diurnal peak flow variability of greater than 20%
4. Corticosteroid refractory asthma, as defined by a less than 15% improvement in FEV1 following a 14-day course of prednisolone 40 mg/1.73 m^2/days 29 - 31
5. Written informed consent received

Exclusion Criteria

1. Past or present disease, which, as judged by the investigator, may affect the study outcome (other than asthma, rhinitis or eczema)
2. Serum corrected calcium greater than 2.66 mmol/l
3. Clinically significant deviation from normal (physical examination or laboratory parameters) as judged by the investigator at the screening visit
4. Current smoker or an ex-smoker of less than 5 years with a greater than 5 pack year history
5. Pregnant or lactating females or those at risk of pregnancy (women of childbearing age may be offered a pregnancy test prior to recruitment)
6. History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks of the screening visit requiring oral corticosteroid tablets
7. Participation in a study involving an investigational medicinal product in the previous 3 months or blood donation within the last year
8. Participants taking regular medications for diseases other than those for asthma or rhinitis
9. Current or previous allergen immunotherapy
10. Concomitant treatment with a thiazide diuretic or calcium supplement
11. Inability to understand or comply with the research protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified