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Vitamin D to Prevent Severe Asthma Exacerbations (Vit-D-Kids Asthma)

NCT02687815 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2021-08-12

Study results available
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Summary

This study will determine whether vitamin D3 prevents severe asthma attacks in children who have a serum vitamin D (25(OH)D) level \<30 ng/ml and who are being treated with inhaled corticosteroids for asthma. Half the participants will receive vitamin D3 at a dose of 4,000 IU/day, and the other half will receive placebo.

Conditions

Interventions

DRUG

vitamin D3 4000 IU

The vitamin D3 will be in oral gel cap form and contain 4000 International Units (IU) of cholecalciferol per gel cap.

DRUG

Placebo

The placebo is a gel cap that is indistinguishable from the vitamin D3 gel cap.

Sponsors & Collaborators

  • Pharmavite LLC

    collaborator INDUSTRY

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Juan Celedon, MD

    lead OTHER

Principal Investigators

  • Juan C. Celedón, MD, DrPH · University of Pittsburgh

  • Stephen Wisniewski, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-22
Primary Completion
2019-09-17
Completion
2019-09-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02687815 on ClinicalTrials.gov