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

NCT02687815 | Terminated Phase 2 Results DMC

• 2 other identifiers: PRO12020541U01HL119952
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 7

Brief 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

Asthma

Keywords

Vitamin D, severe asthma exacerbations, children

Outcome Measures

Primary Outcomes (1)

• Days to a Severe Asthma Exacerbation

  A severe asthma exacerbation is defined as an exacerbation that meets either of these criteria: 1) Use of systemic corticosteroids (tablets, suspension, or injection), or an increase from a stable maintenance dose, for at least 3 days OR 2) A hospitalization or ER visit because of asthma, requiring systemic corticosteroids.

  48 weeks

Secondary Outcomes (3)

• Days to Viral-induced Severe Exacerbation

  48 weeks

• Proportion of Participants in Whom Fluticasone Dose Was Halved at Visit 6

  24 weeks

• Average Cumulative Prescribed Dose of ICS at the End of the Trial

  48 weeks

Study Arms (2)

vitamin D3

EXPERIMENTAL

Cholecalciferol (Vitamin D3) 4000 IU oral gel cap daily

Drug: vitamin D3 4000 IU

placebo

PLACEBO COMPARATOR

placebo formulations will be in gel cap form and identical to the active drug

Drug: Placebo

Interventions

vitamin D3 4000 IU DRUG

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

Also known as: Cholecalciferol

vitamin D3

Placebo DRUG

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

placebo

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 16 years old
• Physician-diagnosed asthma for at least one year
• At least one severe asthma exacerbation in the previous year
• Use of asthma medications (daily controller medication \[ICS or leukotriene inhibitor\] or inhaled β2-agonist \[at least three days per week\]) for at least six months in the previous year
• Vitamin D insufficiency (i.e., serum vitamin D (25(OH)D level \<30 ng/ml (75 nmol/L))
• FEV1 ≥70 % of predicted
• Positive bronchodilator response (i.e., increase in FEV1 ≥8% from baseline after inhaled short acting beta agonist or increased airway responsiveness to methacholine (PC20 ≤8 mg/ml if not on ICS or PC20 ≤16 mg/ml if on ICS)
• Study protocol (i.e., age-appropriate dose of Fluticasone and no other asthma controller medications) approved by the child's regular doctor
• Parental consent and child's assent to participate in the study.
• Adherence with ICS and study medication (≥75% use \[at least 21 of 28 days\]) during the run-in period
• Willingness to be randomized and complete study

You may not qualify if:

• Serum calcium \>10.8 mg/dl
• Serum 25(OH) D \<14 ng/ml (35 nmol/L)
• Chronic respiratory disorder other than asthma
• Severe asthma (intubation for asthma at any time OR ≥3 hospitalizations for asthma in previous year OR ≥6 severe asthma exacerbations in previous year)
• Hepatic/renal disease, rickets, malabsorption, or other diseases that would affect vitamin D metabolism
• Current smoking, or former smoking if ≥5 pack-years
• Immune deficiency, cleft palate or Down's syndrome
• Treatment with anticonvulsants or ≥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 trials 30 days before or during the study
• Participant is currently breast feeding an infant
• Pregnancy
• Weight less than 10 kg
• Plans to move out of the study site area in the next year

Sponsors & Collaborators

• Juan Celedon, MD: lead
• Pharmavite LLC: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (7)

University of California - San Francisco

San Francisco, California, 94102, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Saint Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (2)

• Han YY, Forno E, Bacharier LB, Phipatanakul W, Guilbert TW, Cabana MD, Ross K, Blatter J, Rosser FJ, Durrani S, Luther J, Wisniewski SR, Celedon JC. Vitamin D supplementation, lung function and asthma control in children with asthma and low vitamin D levels. Eur Respir J. 2021 Oct 28;58(4):2100989. doi: 10.1183/13993003.00989-2021. Print 2021 Oct.

  PMID: 34326185 DERIVED

• Forno E, Bacharier LB, Phipatanakul W, Guilbert TW, Cabana MD, Ross K, Covar R, Gern JE, Rosser FJ, Blatter J, Durrani S, Han YY, Wisniewski SR, Celedon JC. Effect of Vitamin D3 Supplementation on Severe Asthma Exacerbations in Children With Asthma and Low Vitamin D Levels: The VDKA Randomized Clinical Trial. JAMA. 2020 Aug 25;324(8):752-760. doi: 10.1001/jama.2020.12384.

  PMID: 32840597 DERIVED

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

Limitations and Caveats

Limited statistical power to determine if vitamin D supplementation prolongs the time to a severe asthma exacerbation in children with vitamin D level \<20 ng/ml.

Results Point of Contact

• Title: Dr. Juan Celedón
• Organization: University of Pittsburgh

juan.celedon@chp.edu

(412) 692-8429

Study Officials

• Juan C. Celedón, MD, DrPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Stephen Wisniewski, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Niels K. Jerne Professor of Pediatrics

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 22, 2016
• Study Start: February 22, 2016
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: August 12, 2021
• Results First Posted: November 3, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)