Vitamin D and Severe Asthma Exacerbations

Asthma Clinical Trial

— SAVED-P  

Official title:

A Phase I Trial for Children With Vitamin D Insufficiency and High Risk of Severe Asthma Exacerbations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01921894
• Other study ID #: SAVED-P
• Status: Recruiting
• Phase: Phase 1
• First received: August 9, 2013
• Last updated: August 9, 2013
• Start date: August 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2013
• Source: University of Pittsburgh
• Contact: Rose Lanzo, BS, RT
• Phone: 412-692-5872
• Email: rose.lanzo[@]chp.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study of vitamin D is designed to assess both the safety and efficacy of potential doses (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short period of time (e.g. 4 weeks or less) compared to 200 IU/day.

In children with vitamin D insufficiency or deficiency who are at risk for severe asthma exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and 2,000 IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000 IU/day) will result in a larger proportion of subjects achieving this level within 4 weeks.

Description:

Asthma is a major public health problem in the United States and worldwide. Severe disease exacerbations account for the majority of costs attributable to asthma in the United States. Vitamin D is an essential nutrient with significant immuno-modulatory effects. The observation that vitamin D insufficiency and asthma share risk factors such as urban residence, obesity, and African American ethnicity has generated significant interest in exploring a link between these two conditions.

This is an 8-week randomized, double-masked, controlled trial of vitamin D3 (2,000 IU/day and 4,000 IU/day) to achieve vitamin D sufficiency (a serum 25(OH)D ≥30 ng/ml in 60 school-aged children (ages 6 to 14 years) who have vitamin D insufficiency (a serum 25(OH)D <30 ng/ml) and are at risk for severe asthma exacerbations, but whose asthma that is well-controlled on medium-dose inhaled corticosteroid (ICS) at the end of a 4-week run-in period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• Be at least 6 years of age and younger than 15 years of age

• Have physician-diagnosed asthma

• Taking a medium dose of ICS (e.g. fluticasone 220mcg BID) for daily asthma control for at least 6 months in the prior year.

• Have had a severe asthma exacerbation in the previous year, defined as an Emergency Department (ED) visit, hospitalization, or unscheduled clinic visit for asthma resulting in intramuscular, intravenous, or oral steroids.

• Have bronchodilator responsiveness (BDR, an increase in FEV1 =12% from baseline after administration of inhaled albuterol) or (if no BDR) increased airway responsiveness to methacholine challenge

• Have vitamin D insufficiency (a serum vitamin D (25(OH)D) level <30 ng/ml)

• Have his/her parents give voluntary written consent to participate in the study

Exclusion Criteria:

• Chronic respiratory disorder other than asthma (e.g., bronchiectasis).

• Severe asthma, as evidenced by any of the following: a) chronic need for medication other than single controller therapy and inhaled ß2-agonist, b) intubation for asthma at any time, and c) =2 hospitalizations or =6 severe asthma exacerbations in the previous year

• History of cigarette smoking in the prior year or former smoking if =5 pack-years

• Hepatic or renal disease, metabolic rickets, malabsorptive disorders, or other chronic diseases that would affect vitamin D metabolism

• Immune deficiency, cleft palate or Down's syndrome, which might increase the child's likelihood of respiratory infections

• Treatment with anticonvulsants or pharmacological doses of vitamin D (=1,000 IU/day of vitamin D2 or D3)

• Chronic oral corticosteroid therapy

• Inability to perform acceptable spirometry

• Use of investigational therapies or participation in clinical trials 30 days before or during the duration of the study

• Serum calcium >10.8 mg/dl

• Serum 25(OH) D <10 ng/ml (severe vitamin D deficiency)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma

Intervention

Dietary Supplement:
• Cholecalciferol

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D level	The primary outcome of the proposed trial will be a sufficient (=30 ng/ml) vitamin D level after 4 weeks of supplementation	4 weeks	No
Secondary	Vitamin D levels	to both monitor for vitamin D toxicity and assess the stability of vitamin D levels after supplementation with the two different intervention doses.	8 weeks	Yes
Secondary	Urinary calcium/creatinine ratio	to assess safety by monitoring for Vitamin D toxicity	4 and 8 weeks	Yes
Secondary	Measures of lung function	Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity) and FEV1/FVC (forced vital capacity) (adjusted for age and sex), and bronchodilator responsiveness (BDR, expressed as a percentage of the baseline FEV1 [?FEV1=[(post-bronchodilator FEV1 - baseline FEV1)/baseline FEV1] x 100).	8 weeks	No