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Vitamin D and Severe Asthma Exacerbations (SAVED-P)

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ClinicalTrials.gov Identifier: NCT01921894
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Juan Celedon, MD, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Asthma Dietary Supplement: Cholecalciferol Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase I Trial for Children With Vitamin D Insufficiency and High Risk of Severe Asthma Exacerbations
Study Start Date : August 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D

Arm Intervention/treatment
Experimental: Cholecalciferol 4000 IU
Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
Dietary Supplement: Cholecalciferol
vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
Other Name: vitamin D3

Experimental: Cholecalciferol 2000 IU
Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
Dietary Supplement: Cholecalciferol
vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
Other Name: vitamin D3

Active Comparator: Cholecalciferol 200 IU
Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
Dietary Supplement: Cholecalciferol
vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
Other Name: vitamin D3




Primary Outcome Measures :
  1. Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation [ Time Frame: 8 weeks ]
    The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation

  2. Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation [ Time Frame: 4 weeks ]
    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 :
  1. Number of Participants With Vitamin D Toxicity [ Time Frame: 8 weeks ]
    Participants with vitamin D toxicity, hypercalcemia (>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (>0.37)

  2. Number of Participants With Elevated Urinary Calcium/Creatinine Ratio [ Time Frame: 4 and/or 8 weeks ]
    Elevated urinary calcium/creatinine ratio defined as UCa/UCr > 0.37 after either 4 weeks or 8 weeks of supplementation

  3. Number of Participants With FEV1 < 80% of Predicted [ Time Frame: 8 weeks ]
    Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921894


Locations
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United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Juan C Celedon, M.D., Dr.P.H. University of Pittsburgh

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Responsible Party: Juan Celedon, MD, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01921894     History of Changes
Other Study ID Numbers: SAVED-P
First Posted: August 13, 2013    Key Record Dates
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Juan Celedon, MD, University of Pittsburgh:
asthma
vitamin D

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents