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

NCT04117581 | Completed

• 1 other identifier: 1583/19/SW/CSN
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Vitamin D Deficiency; Nutritional Deficiency; Inflammation

Keywords

Vitamin D; Asthma; Lung function; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in Asthma Control Test™ score

  0 weeks, 6 weeks, 12 weeks

• Change in vitamin D concentration from baseline to 12 weeks

  0 weeks, 6 weeks, 12 weeks

• Change in parathyroid hormone (PTH) concentration from baseline to 12 weeks

  0 weeks, 6 weeks, 12 weeks

• Change in Full Blood Count Concentration from baseline to 12 weeks

  0 weeks, 6 weeks, 12 weeks

• Change in interferon-gamma (IFN-ϒ) concentration from baseline to 12 weeks

  0 weeks, 6 weeks, 12 weeks

Study Arms (2)

Vitamin D3 supplement

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Participants will be asked to take one capsule of placebo (inert filler) daily for a total duration of 12 weeks.

Other: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

5000 IU (125 μg) vitamin D3 capsules daily over 12 weeks (84 days)

Also known as: Cholecalciferol

Vitamin D3 supplement

Placebo OTHER

Inert filler capsules daily over 12 weeks (84 days)

Also known as: Non active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chester: lead

Study Sites (1)

University of Chester

Chester, Chesire, CH1 4BJ, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Vitamin D Deficiency; Malnutrition; Inflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Avitaminosis; Deficiency Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sohail Mushtaq, PhD

  University of Chester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 7, 2019
• Study Start: October 28, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)