Vitamin D and Severe Asthma Exacerbations

NCT01921894 | Completed Phase 1 Results

• 1 other identifier: SAVED-P
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; vitamin D

Outcome Measures

Primary Outcomes (2)

• 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

  8 weeks

• 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

  4 weeks

Secondary Outcomes (3)

• Number of Participants With Vitamin D Toxicity

  8 weeks

• Number of Participants With Elevated Urinary Calcium/Creatinine Ratio

  4 and/or 8 weeks

• Number of Participants With FEV1 < 80% of Predicted

  8 weeks

Study Arms (3)

Cholecalciferol 4000 IU

EXPERIMENTAL

Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks

Dietary Supplement: Cholecalciferol

Cholecalciferol 2000 IU

EXPERIMENTAL

Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks

Dietary Supplement: Cholecalciferol

Cholecalciferol 200 IU

ACTIVE COMPARATOR

Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks

Dietary Supplement: Cholecalciferol

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.

Also known as: vitamin D3

Cholecalciferol 200 IU; Cholecalciferol 2000 IU; Cholecalciferol 4000 IU

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Juan C. Celedon, Niels K. Jerne Professor of Pediatrics
• Organization: University of Pittsburgh

juan.celedon@chp.edu

412-692-8429

Study Officials

• Juan C Celedon, M.D., Dr.P.H.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 13, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 23, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)