Trial of Vitamin D Supplementation in Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Dietary Supplement: Cholecalciferol; Dietary Supplement: Miglyol oil

• Registration Number: NCT00978315
• Lead Sponsor: Barts & The London NHS Trust

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 asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-14
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vigantol oil	Cholecalciferol	Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
Miglyol oil	Miglyol oil	Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year

Primary Outcome Measures

Name	Time	Method
Time to first severe asthma exacerbation	One year
Time to first upper respiratory tract infection	One year

Secondary Outcome Measures

Name	Time	Method
Asthma Control Test Score	One year
Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation	One year
Proportion of participants experiencing hypercalcaemia	One year

Trial Locations

Locations (4)

Barts and The London NHS Trust; 🇬🇧 London, United Kingdom

Homerton University Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Lower Clapton Health Centre; 🇬🇧 London, United Kingdom

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom