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 :
Active, not recruiting
First Posted : October 7, 2019
Last Update Posted : February 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Asthma Vitamin D Deficiency Nutritional Deficiency Inflammation | Dietary Supplement: Vitamin D3 Other: Placebo | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 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 2022 |
Estimated Study Completion Date : | July 2022 |

Arm | Intervention/treatment |
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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.
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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.
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Other: Placebo
Inert filler capsules daily over 12 weeks (84 days)
Other Name: Non active ingredient |
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Males or females aged 18 years to 65 years
- Asthma diagnosed by a general practitioner
- Taking inhaled therapy to treat asthma that is required at least two times per week
Exclusion Criteria:
- Taking vitamin D supplements or supplements containing calcium
- History of asthma requiring treatment with intubation and mechanical ventilation within the past five years
- Require inhaled asthma therapy more than four times per day
- Respiratory tract infection within the past four weeks
- Suffering from chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency
- History of smoking within the past year or > 10 years total
- 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
- Unable to communicate in English

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
United Kingdom | |
University of Chester | |
Chester, Chesire, United Kingdom, CH1 4BJ |
Principal Investigator: | Sohail Mushtaq, PhD | University of Chester |
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: | February 18, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Vitamin D Asthma Lung function Inflammation |
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 Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |