Asthma Clinical Trial
— VITDASOfficial title:
A Daily 5000 IU Vitamin D Supplement for the Improvement of Lung Function and Asthma Control in Adults With Asthma: a Randomised Controlled Trial
Verified date | February 2022 |
Source | University of Chester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Asthma is a disease characterised by chronic inflammation of the airways leading to symptoms including periods of shortness of breath, wheezing and a tight chest due to airway narrowing in affected patients. Current data show that one in 12 adults are currently receiving treatment for asthma in the United Kingdom (UK), with the UK having some of the highest rates in Europe. In the winter, 30-40% of the UK population are vitamin D deficient with some asthma patients having significantly lower vitamin D levels compared to normal patients. Vitamin D has been shown to be involved in the development of immune-related disorders including asthma. Cross-sectional research has shown that reduced vitamin D levels are associated with reduced lung function, increased airway hyper-responsiveness and reduced response to glucocorticoids, suggesting vitamin D levels may also implicate asthma treatment. To date, there have been three randomised controlled trials (RCT) assessing the effect of vitamin D supplementation in adults with symptomatic asthma. These trials have not found a significant effect of vitamin D supplementation on asthma. However, these studies relied on high doses of vitamin D with long time periods between doses. There is a requirement for RCTs in adults with daily supplementation of lower doses of vitamin D as it has been suggested that daily supplementation is more effective for inducing non-classical actions of vitamin D. However, vitamin D has been found to significantly improve airway function as measured by forced expiratory volume in one second (FEV1) in adults supplemented with 100, 000 international units (IU) vitamin D intramuscularly plus 50, 000 IU oral vitamin D weekly. Therefore, the effect of daily dosing on lung function also requires investigation. Furthermore, these trials have focussed on clinical outcomes without investigating the cellular mechanisms affording protection.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Males or females aged 18 years to 65 years 2. Asthma diagnosed by a general practitioner 3. Taking inhaled therapy to treat asthma that is required at least two times per week Exclusion Criteria: 1. Taking vitamin D supplements or supplements containing calcium 2. History of asthma requiring treatment with intubation and mechanical ventilation within the past five years 3. Require inhaled asthma therapy more than four times per day 4. Respiratory tract infection within the past four weeks 5. Suffering from chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency 6. History of smoking within the past year or > 10 years total 7. Been on a sun holiday within a month of taking part in the study or during the study. For the purpose of this study a sun holiday is defined as: spending one week or more in a hotter climate with the intention of sun-bathing 8. Unable to communicate in English |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Chester | Chester | Chesire |
Lead Sponsor | Collaborator |
---|---|
University of Chester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in lung function from baseline to 12 weeks | Forced expiratory volume in one second (FEV1) and forced expiratory volume (FVC) measured by spirometry | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in Asthma Control Test™ score | Indication of level of asthma control according to participant. Score between 0 and 25.
Scores indicate: 25: Asthma appears to have been under control over the last 4 weeks 20 - 24: Asthma appears to have been reasonably well controlled over the last 4 weeks Less than 20: Asthma may not have been controlled during the past 4 weeks |
0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in vitamin D concentration from baseline to 12 weeks | Vitamin D3 status measured in plasma samples by enzyme-linked immunosorbent assay (ELISA) commercial kit | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in parathyroid hormone (PTH) concentration from baseline to 12 weeks | Vitamin D metabolism biomarker measured in plasma samples by ELISA commercial kit | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in Full Blood Count Concentration from baseline to 12 weeks | Percentage granulocytes measured in whole blood samples by Beckman Coulter haematological analyser | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in interferon-gamma (IFN-?) concentration from baseline to 12 weeks | Inflammatory biomarker measured in plasma samples by ELISA commercial kit | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in tumour-necrosis-factor-alpha (TNF-a) concentration from baseline to 12 weeks | Inflammatory biomarker measured in plasma samples by ELISA commercial kit | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in C-reactive protein (CRP) concentration from baseline to 12 weeks | Inflammatory biomarker measured in plasma samples by ELISA commercial kit | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in immunoglobulin E (IgE) concentration from baseline to 12 weeks | Antibody measured in plasma samples by ELISA commercial kit | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in interleukin-(IL)4 concentration from baseline to 12 weeks | Inflammatory biomarker measured in plasma samples by ELISA commercial kit | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in IL-10 concentration from baseline to 12 weeks | Inflammatory biomarker measured in plasma samples by ELISA commercial kit | 0 weeks, 6 weeks, 12 weeks | |
Secondary | Change in IL-13 concentration from baseline to 12 weeks | Inflammatory biomarker measured in plasma samples by ELISA commercial kit | 0 weeks, 6 weeks, 12 weeks |
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