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Trial record 4 of 14 for:    asthma | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | "vitamin d"

A Study to Investigate the Effect of Vitamin D3 Supplementation on Asthma Symptoms in Adults With Asthma (VITDAS) (VITDAS)

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ClinicalTrials.gov Identifier: NCT04117581
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Vitamin D Deficiency Nutritional Deficiency Inflammation Dietary Supplement: Vitamin D3 Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D3 supplement
Participant will be asked to take one capsule of vitamin D3 supplement (5000 IU) (125 μg) daily for a total duration of 12 weeks.
Dietary Supplement: Vitamin D3
5000 IU (125 μg) vitamin D3 capsules daily over 12 weeks (84 days)
Other Name: Cholecalciferol

Placebo Comparator: Placebo
Participants will be asked to take one capsule of placebo (inert filler) daily for a total duration of 12 weeks.
Other: Placebo
Inert filler capsules daily over 12 weeks (84 days)
Other Name: Non active ingredient




Primary Outcome Measures :
  1. Change in lung function from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Forced expiratory volume in one second (FEV1) and forced expiratory volume (FVC) measured by spirometry


Secondary Outcome Measures :
  1. Change in Asthma Control Test™ score [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]

    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


  2. Change in vitamin D concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Vitamin D3 status measured in plasma samples by enzyme-linked immunosorbent assay (ELISA) commercial kit

  3. Change in parathyroid hormone (PTH) concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Vitamin D metabolism biomarker measured in plasma samples by ELISA commercial kit

  4. Change in Full Blood Count Concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Percentage granulocytes measured in whole blood samples by Beckman Coulter haematological analyser

  5. Change in interferon-gamma (IFN-ϒ) concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Inflammatory biomarker measured in plasma samples by ELISA commercial kit

  6. Change in tumour-necrosis-factor-alpha (TNF-α) concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Inflammatory biomarker measured in plasma samples by ELISA commercial kit

  7. Change in C-reactive protein (CRP) concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Inflammatory biomarker measured in plasma samples by ELISA commercial kit

  8. Change in immunoglobulin E (IgE) concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Antibody measured in plasma samples by ELISA commercial kit

  9. Change in interleukin-(IL)4 concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Inflammatory biomarker measured in plasma samples by ELISA commercial kit

  10. Change in IL-10 concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Inflammatory biomarker measured in plasma samples by ELISA commercial kit

  11. Change in IL-13 concentration from baseline to 12 weeks [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Inflammatory biomarker measured in plasma samples by ELISA commercial kit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117581


Contacts
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Contact: Sohail Mushtaq, PhD 01244519967 ext 3367 s.mushtaq@chester.ac.uk

Locations
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United Kingdom
University of Chester Recruiting
Chester, Chesire, United Kingdom, CH1 4BJ
Contact: Sohail Mushtaq, PhD    01244 513367 ext 3367    s.mushtaq@chester.ac.uk   
Contact: Stephanie Watkins, MBiolSci    01244 511198 ext 1198    s.watkins@chester.ac.uk   
Sponsors and Collaborators
University of Chester
Investigators
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Principal Investigator: Sohail Mushtaq, PhD University of Chester
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Responsible Party: University of Chester
ClinicalTrials.gov Identifier: NCT04117581    
Other Study ID Numbers: 1583/19/SW/CSN
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chester:
Vitamin D
Asthma
Lung function
Inflammation
Additional relevant MeSH terms:
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Asthma
Vitamin D
Vitamin D Deficiency
Malnutrition
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Avitaminosis
Deficiency Diseases
Nutrition Disorders
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents