Findings from observational studies by our group and others suggest that vitamin D insufficiency (a common condition) is associated with an increased risk of severe asthma exacerbations in school-aged children. We hypothesize that vitamin D supplementation reduces the incidence of severe asthma exacerbations in high-risk (so defined due to an exacerbation in the previous year) children aged 6 to 14 years who have vitamin D insufficiency (a serum 25(OH) D <30 ng/ml) and who are being treated with inhaled corticosteroids (ICS) for mild to moderate persistent asthma. We further hypothesize that this protective effect results from a reduced incidence of viral infections that lead to severe asthma exacerbations and/or enhanced response to ICS in these children. We will test this hypothesis in a randomized double-masked placebo-controlled clinical trial with the following primary and secondary Specific Aims: Primary Specific Aim 1) To determine whether vitamin D3 supplementation (4,000 IU/day) is superior to placebo in preventing severe asthma exacerbations in high-risk school-aged children who have vitamin D insufficiency and who are on ICS for mild to moderate persistent asthma. Secondary Specific Aims In high-risk school-aged children with vitamin D insufficiency who are on ICS for asthma, to determine whether vitamin D3 supplementation is superior to placebo in: 1) Preventing severe asthma exacerbations resulting from viral infections 2) Reducing the daily dose of ICS as well as the average cumulative dose of ICS, at the end of the trial

Public Health Relevance

Identifying new strategies to prevent severe asthma exacerbations would have a major impact on clinical practice and public health. This application will determine whether high-dose vitamin D supplementation should be recommended as adjuvant therapy to inhaled corticosteroids for high-risk school-aged children with mild to moderate persistent asthma and vitamin D insufficiency. To accomplish this goal, we have assembled a research team with expertise in asthma epidemiology, vitamin D and asthma, and clinical trials.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL119952-01A1
Application #
8899713
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Noel, Patricia
Project Start
2015-06-15
Project End
2020-05-31
Budget Start
2015-06-15
Budget End
2016-05-31
Support Year
1
Fiscal Year
2015
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Pediatrics
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Forno, Erick; Han, Yueh-Ying; Mullen, James et al. (2018) Overweight, Obesity, and Lung Function in Children and Adults-A Meta-analysis. J Allergy Clin Immunol Pract 6:570-581.e10
Han, Yueh-Ying; Forno, Erick; Canino, Glorisa et al. (2018) Psychosocial risk factors and asthma among adults in Puerto Rico. J Asthma :1-9
Rosser, Franziska; Han, Yueh-Ying; Forno, Erick et al. (2018) Urinary polycyclic aromatic hydrocarbons and allergic sensitization in a nationwide study of children and adults in the United States. J Allergy Clin Immunol 142:1641-1643.e6
Han, Yueh-Ying; Forno, Erick; Shivappa, Nitin et al. (2018) The Dietary Inflammatory Index and Current Wheeze Among Children and Adults in the United States. J Allergy Clin Immunol Pract 6:834-841.e2
Forno, Erick; Han, Yueh-Ying; Libman, Ingrid M et al. (2018) Adiposity and Asthma in a Nationwide Study of Children and Adults in the United States. Ann Am Thorac Soc 15:322-330
Szentpetery, Sylvia E; Han, Yueh-Ying; Brehm, John M et al. (2018) Vitamin D insufficiency, plasma cytokines, and severe asthma exacerbations in school-aged children. J Allergy Clin Immunol Pract 6:289-291.e2
Han, Yueh-Ying; Forno, Erick; Celedón, Juan C (2018) Anxiety and noneosinophilic asthma among adults in the United States. J Allergy Clin Immunol Pract :
Han, Yueh-Ying; Forno, Erick; Boutaoui, Nadia et al. (2018) Vitamin D insufficiency, TH2 cytokines, and allergy markers in Puerto Rican children with asthma. Ann Allergy Asthma Immunol 121:497-498.e1
Han, Yueh-Ying; Rosser, Franziska; Forno, Erick et al. (2018) Exposure to polycyclic aromatic hydrocarbons, vitamin D, and lung function in children with asthma. Pediatr Pulmonol 53:1362-1368
Peters, Ubong; Dixon, Anne E; Forno, Erick (2018) Obesity and asthma. J Allergy Clin Immunol 141:1169-1179

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