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AsthmaPhase 2NCT01210521

Use of Vitamin D3 for the Treatment of Steroid Resistant Asthmatic Patients

A Phase 2 study testing Vitamin D in people with Asthma, run by Florida Atlantic University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to determine the effects of vitamin D3 on severe asthmatic patients. Vitamin D3 may alter the response of these patients to conventional steroid therapy, making them more responsive to the latter form of treatment. Read more about this study

Who is it for?
Ages 12 to 70 years
Conditions the study is for
Asthma
What is being tested?
Vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2010to Feb 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Inclusion Criteria: Diagnosis of severe steroid resistant asthmatic as defined by the American Thoracic Society workshop 2000. Patients must have been diagnosed for at least one year prior to the study. Patients must exhibit one or more major criteria and two minor criteria from the following list to be included in the study:

Definition of Severe Asthma by American Thoracic Society Consensus (2000). Major Characteristics

In order to achieve control to a level of mild-moderate persistent asthma:

  1. Treatment with continuous or near continuous (>50% of year) oral corticosteroids
  2. Requirement for treatment with high-dose inhaled corticosteroids:

Drug Dose (µg/d) Dose (puffs/d)

  1. Beclomethasone dipropionate. > 1,260. > 40 puffs (42 µg /inhalation). > 20 puffs (84 µg/inhalation)
  2. Budesonide > 1,200 > 6 puffs
  3. Flunisolide > 2,000 > 8 puffs
  4. Fluticasone propionate > 880 > 8 puffs(110µg), >4puffs(220 µg)
  5. Triamcinolone acetonide > 2,000 > 20 puffs

Minor Characteristics

  1. Requirement for daily treatment with a controller medication in addition to inhaled corticosteroids, e.g., long-acting β-agonist, theophylline, or leukotriene antagonist
  2. Asthma symptoms requiring short-acting β-agonist use on a daily or near daily basis
  3. Persistent airway obstruction (FEV1,80% predicted; diurnal PEF variability >20%)
  4. One or more urgent care visits for asthma per year
  5. Three or more oral steroid "bursts" per year
  6. Prompt deterioration with<25% reduction in oral or inhaled corticosteroid dose
  7. Near fatal asthma event in the past Additional minor characteristics include : normal diffusing capacity and methacholine PC20 be less than 8mg.

Exclusion Criteria: Patients diagnosed with the following conditions will be excluded:

Vitamin D resistant rickets, chronic renal failure, hypercalcemia (secondary to hyperparathyroidism or malignancy), Chronic Obstructive Pulmonary Disease, severe malabsorption syndrome, sarcoidosis, patients taking cardiac glycosides for cardiac arrythmias.

Pregnant or nursing women, and smoking patients will be excluded.

About this study

The purpose of this study is to determine the effects of vitamin D3 on severe asthmatic patients. Vitamin D3 may alter the response of these patients to conventional steroid therapy, making them more responsive to the latter form of treatment. Patients will be treated daily with an oral dose (2,000 IU) of vitamin D3 for one month and their clinical and serological parameters, and immune function, will be evaluated. Results from pre- and post-vitaminD3 treatment will be compared.

Read the detailed description

Asthma is one of the most common chronic diseases in childhood and one of the leading causes of morbidity in children. Its incidence has been growing, especially in the Western, highly industrialized nations. Glucocorticoids are used for the treatment of many inflammatory and autoimmune diseases, among them asthma, because they can switch off genes that code for pro- inflammatory cytokines and chemokines. Unfortunately, there is a substantial group of severe asthma patients that are steroid resistant. In addition, they suffer from the long term side effects of systemic steroid use.

Vitamin D3 plays an important role in the maintenance of several organ systems and its deficiency causes multiple and complex dysfunctions for the organism. Vitamin D3 has been originally described to regulate calcemia by absorbing calcium in the intestine and by increasing re-absorption of calcium in the kidneys. Recent studies have shown the important effects of Vitamin D3 on many other systems, especially as a modulator of the immune system, and its deficiency has been linked to several autoimmune and inflammatory diseases such as multiple sclerosis, inflammatory bowel disease, lupus erythematosus, rheumatoid arthritis and asthma.

Vitamin D inhibits the dysregulated antibody synthesis that is seen in asthmatics. It inhibits the proliferation of immune cells that produce inflammatory substances, and conversely, vitamin D enhances the function and proliferation of regulatory cells, through the induction of IL-10 producing T regulatory cells, and a very effective group of T regulatory cells characterized as CD4+ CD25+ FoxP3+ . Dendritic cell (DC) function is also modulated by Vitamin D. 1,25(OH)2vitaminD3 appears to generate tolerogenic dendritic cells (DC) in vivo, as demonstrated in models of transplantation and autoimmune diseases. Immature/tolerogenic DCs induce development of T regulatory cells by several mechanisms, including production of IL-10 or TGF-beta. Vitamin D3 increases the glucocorticoid receptor expression in asthmatic patients' T cells. In an interesting study on an asthma mouse model, treatment with Vitamin D combined with immunotherapy resulted in increased production of the inhibitory cytokine IL-10 in lung tissue and increased levels of TGF-beta in serum.

Overall these studies and others, support the hypothesis that Vitamin D induces regulatory T cells that are crucial for the control of autoimmune diseases such as asthma.

In spite of this attractive conceptual link between the benefits of vitamin D and immune regulation in SR asthma, no study has presented clinical data, i.e., pulmonary functions, quality of life score, reduction in steroid dose and other medications, and indices of better asthma control. There is also a dearth of ex-vivo data in order to confirm or refute in-vitro results. There is very little data that characterizes the effects of vitamin D supplementation on immune cells, cytokines, and asthma mediators.

Conditions
Asthma
Being tested
Vitamin D
Keywords
Asthmatic Patients, Vitamin D, Steroid Resistant Asthmatic Patients, cholecalciferol
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDrug

    Vitamin D, (2000IU) will be administered orally, once a day, for one month.

Study groups in NCT01210521
Study groupRoleWhat they receive
Prior to intervention with Vitamin DNo interventionPatients will be analyzed for clinical, serological and immunological parameters before starting the interventional drug, Vitamin D.
Vitamin D InterventionActive comparatorPatients will be analyzed for clinical, serological and immunological parameters after one month taking Vitamin D.
Receives: Drug: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary Function Test

    A pulmonary function test or spirometry, measures lung function by determining the volume and flow of air that can be inhaled or exhaled. FEV1is determined.

    Measured: Six months

Secondary outcomes (1)

  1. Concentration of Interleukin 10(IL-10),in serum.

    The concentration of IL-10,in serum will be determined by ELISA.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Why it stopped: Sponsor terminated study due to inability to enroll subjects.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01210521
Sponsor's protocol ID
WIRB1116133
Status last verified
Aug 2016
First submitted
27 Sep 2010
Last updated
10 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Study withdrwan

Publications

  • Litonjua AA. Childhood asthma may be a consequence of vitamin D deficiency. Curr Opin Allergy Clin Immunol. 2009 Jun;9(3):202-7. doi: 10.1097/ACI.0b013e32832b36cd.

    PubMed 19365260

  • Xystrakis E, Kusumakar S, Boswell S, Peek E, Urry Z, Richards DF, Adikibi T, Pridgeon C, Dallman M, Loke TK, Robinson DS, Barrat FJ, O'Garra A, Lavender P, Lee TH, Corrigan C, Hawrylowicz CM. Reversing the defective induction of IL-10-secreting regulatory T cells in glucocorticoid-resistant asthma patients. J Clin Invest. 2006 Jan;116(1):146-55. doi: 10.1172/JCI21759. Epub 2005 Dec 8.

    PubMed 16341266

  • Taher YA, van Esch BC, Hofman GA, Henricks PA, van Oosterhout AJ. 1alpha,25-dihydroxyvitamin D3 potentiates the beneficial effects of allergen immunotherapy in a mouse model of allergic asthma: role for IL-10 and TGF-beta. J Immunol. 2008 Apr 15;180(8):5211-21. doi: 10.4049/jimmunol.180.8.5211.

    PubMed 18390702

  • Peterlik M, Cross HS. Vitamin D and calcium insufficiency-related chronic diseases: molecular and cellular pathophysiology. Eur J Clin Nutr. 2009 Dec;63(12):1377-86. doi: 10.1038/ejcn.2009.105. Epub 2009 Sep 2.

    PubMed 19724293

  • Larche M. Regulatory T cells in allergy and asthma. Chest. 2007 Sep;132(3):1007-14. doi: 10.1378/chest.06-2434.

    PubMed 17873195

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin D in people with Asthma, run by Florida Atlantic University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary Function Test (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01210521, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.

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Clinical Trial NCT01210521 | AzTrials