Status:
COMPLETED
Trial of Vitamin D Supplementation in Asthma
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
National Health Service, United Kingdom
Conditions:
Asthma
Eligibility:
All Genders
16-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with ast...
Eligibility Criteria
Inclusion
- Principal
- Medical record diagnosis of asthma
- Age ≥ 16 years and ≤ 80 years on day of first dose of IMP
- If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
- Able to give written informed consent to participate in the study
- Principal
Exclusion
- Diagnosis of COPD
- Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years
- Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
- Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
- Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP
- Treatment with any investigational medical product or device up to 4 months before first dose of IMP
- Breastfeeding, pregnant or planning a pregnancy
- Baseline corrected serum calcium \> 2.65 mmol/L
- Baseline serum creatinine \> 125 micromol/L
- Smoking history \>15 pack-years
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00978315
Start Date
September 1 2009
End Date
July 1 2013
Last Update
February 4 2014
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Barts and The London NHS Trust
London, London, United Kingdom, E1 1BB
2
Lower Clapton Health Centre
London, London, United Kingdom, E5 0PD
3
Homerton University Hospital NHS Foundation Trust
London, London, United Kingdom, E9 6SR
4
Guy's and St Thomas' NHS Foundation Trust
London, London, United Kingdom, SE1 9RT