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Vitamin D and Severe Asthma Exacerbations (SAVED-P)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma, vitamin D

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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 β2-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)

Sites / Locations

  • Children's Hospital of Pittsburgh of UPMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Cholecalciferol 4000 IU

Cholecalciferol 2000 IU

Cholecalciferol 200 IU

Arm Description

Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks

Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks

Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks

Outcomes

Primary Outcome Measures

Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation
The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation
The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation

Secondary Outcome Measures

Number of Participants With Vitamin D Toxicity
Participants with vitamin D toxicity, hypercalcemia (>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (>0.37)
Number of Participants With Elevated Urinary Calcium/Creatinine Ratio
Elevated urinary calcium/creatinine ratio defined as UCa/UCr > 0.37 after either 4 weeks or 8 weeks of supplementation
Number of Participants With FEV1 < 80% of Predicted
Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).

Full Information

First Posted
August 9, 2013
Last Updated
February 2, 2017
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01921894
Brief Title
Vitamin D and Severe Asthma Exacerbations
Acronym
SAVED-P
Official Title
A Phase I Trial for Children With Vitamin D Insufficiency and High Risk of Severe Asthma Exacerbations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 at 4 and 8 weeks.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, vitamin D

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol 4000 IU
Arm Type
Experimental
Arm Description
Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
Arm Title
Cholecalciferol 2000 IU
Arm Type
Experimental
Arm Description
Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
Arm Title
Cholecalciferol 200 IU
Arm Type
Active Comparator
Arm Description
Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
vitamin D3
Intervention Description
vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
Primary Outcome Measure Information:
Title
Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation
Description
The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Time Frame
8 weeks
Title
Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation
Description
The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Vitamin D Toxicity
Description
Participants with vitamin D toxicity, hypercalcemia (>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (>0.37)
Time Frame
8 weeks
Title
Number of Participants With Elevated Urinary Calcium/Creatinine Ratio
Description
Elevated urinary calcium/creatinine ratio defined as UCa/UCr > 0.37 after either 4 weeks or 8 weeks of supplementation
Time Frame
4 and/or 8 weeks
Title
Number of Participants With FEV1 < 80% of Predicted
Description
Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 β2-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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C Celedon, M.D., Dr.P.H.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vitamin D and Severe Asthma Exacerbations

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