Trial of Vitamin D Supplementation in Asthma (ViDiAs)

Barts & The London NHS Trust

Status and phase

Completed

Phase 3

Phase 2

Conditions

Asthma

Treatments

Dietary Supplement: Cholecalciferol

Dietary Supplement: Miglyol oil

Study type

Interventional

Funder types

Other

Identifiers

NCT00978315

2009-010083-42

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

All

Ages

16 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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