Trial of Vitamin D Supplementation in Asthma

Asthma Clinical Trial

— ViDiAs  

Official title:

Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978315
• Other study ID #: 2009-010083-42
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 14, 2009
• Last updated: February 3, 2014
• Start date: September 2009
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Principal Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma

Intervention

Dietary Supplement:
• Cholecalciferol
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
• Miglyol oil
Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year

Locations

Country	Name	City	State
United Kingdom	Barts and The London NHS Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Homerton University Hospital NHS Foundation Trust	London
United Kingdom	Lower Clapton Health Centre	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first upper respiratory tract infection		One year	No
Primary	Time to first severe asthma exacerbation		One year	No
Secondary	Asthma Control Test Score		One year	No
Secondary	Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation		One year	No
Secondary	Proportion of participants experiencing hypercalcaemia		One year	Yes