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

NCT01210521 | Withdrawn Phase 2 DMC

• 1 other identifier: WIRB1116133
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Asthma

Keywords

Asthmatic Patients; Vitamin D; Steroid Resistant Asthmatic Patients; cholecalciferol

Outcome Measures

Primary Outcomes (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.

  Six months

Secondary Outcomes (1)

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

  One year

Study Arms (2)

Prior to intervention with Vitamin D

NO INTERVENTION

Patients will be analyzed for clinical, serological and immunological parameters before starting the interventional drug, Vitamin D.

Vitamin D Intervention

ACTIVE COMPARATOR

Patients will be analyzed for clinical, serological and immunological parameters after one month taking Vitamin D.

Drug: Vitamin D

Interventions

Vitamin D DRUG

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

Vitamin D Intervention

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Treatment with continuous or near continuous (\>50% of year) oral corticosteroids
• Requirement for treatment with high-dose inhaled corticosteroids:
• Drug Dose (µg/d) Dose (puffs/d)
• Beclomethasone dipropionate. \> 1,260. \> 40 puffs (42 µg /inhalation).
• \> 20 puffs (84 µg/inhalation)
• Budesonide \> 1,200 \> 6 puffs
• Flunisolide \> 2,000 \> 8 puffs
• Fluticasone propionate \> 880 \> 8 puffs(110µg), \>4puffs(220 µg)
• Triamcinolone acetonide \> 2,000 \> 20 puffs
• Minor Characteristics
• Requirement for daily treatment with a controller medication in addition to inhaled corticosteroids, e.g., long-acting β-agonist, theophylline, or leukotriene antagonist
• Asthma symptoms requiring short-acting β-agonist use on a daily or near daily basis
• Persistent airway obstruction (FEV1,80% predicted; diurnal PEF variability \>20%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida Atlantic University: lead

Related Publications (5)

• 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.

  PMID: 19365260 BACKGROUND

• 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.

  PMID: 16341266 BACKGROUND

• 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.

  PMID: 18390702 BACKGROUND

• 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.

  PMID: 19724293 BACKGROUND

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

  PMID: 17873195 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• James X Hartmann, PhD

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 28, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share