Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis

NCT01222273 | Completed Results

• 2 other identifiers: PRO090903707P50HL084932-04
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to see if giving people with CF and ABPA enough vitamin D to make their blood levels of the vitamin higher, will reduce the allergic response in their body and make the symptoms caused by ABPA better.

Conditions

Cystic Fibrosis; Allergic Bronchopulmonary Aspergillosis

Keywords

cystic fibrosis; Allergic bronchopulmonary aspergillosis; A. fumigatus; Immune response

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Aspergillus Induced IL-13 Responses in CD4+ T-cells

  To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce Aspergillus induced IL-13 responses in peripheral CD4+ T-cells. Response confirmed for each individual patient and recorded as number of participants with response.

  6 months

Secondary Outcomes (2)

• Change in Patient Total IgE Levels

  6 months

• Change in Patient Aspergillus Specific IgE Levels

  6 months

Study Arms (1)

Open label

OTHER

open label Vitamin D

Dietary Supplement: cholecalciferol (Vitamin D3)

Interventions

cholecalciferol (Vitamin D3) DIETARY_SUPPLEMENT

4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months

Also known as: cholecalciferol

Open label

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 12 years of age at enrollment
• Confirmed diagnosis of CF based on the following criteria:
• One or more clinical features consistent with the CF phenotype AND (b or c)
• Positive sweat chloride \> 60 mEq/liter (by pilocarpine iontophoresis)
• two identifiable mutations consistent with CF
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
• Clinically stable at enrollment as assessed by the site investigator
• Past or present respiratory culture positive for Aspergillus fumigatus
• IgE ≥ 250 and/or presence of class II or higher aspergillus specific IgE on enrollment
• Ability to comply with medication use, study visits and study procedures as judged by the site investigator -

You may not qualify if:

• \. Systemic corticosteroids (1 mg/kg if \< 20 kg or \> 20 mg of prednisone per day),.
• \. Investigational drug use within 30 days of screening 3. Laboratory abnormalities at screening
• a. Serum Calcium \> 11 mg/dl b. 25(OH) D \> 50 ng/ml at screening. c. Creatinine ≥ 1.5, or estimated GFR \<60 by Cockcroft-Gault or MDRD equation. d. LFT≥ 3xULN
• \. History of transplantation or currently on lung transplant list 5. Positive serum pregnancy test at screening (to be performed on all post-menarche females) 6. Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study 7. Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data 8. Diagnosis of HIV and a CD4+ T cell count below 500 cells/ml or active hepatitis B or C infection.
• \. Undergoing therapy for non-tuberculous mycobacterial infection

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Comprehensive Lung Center - Falk Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

• Nguyen NL, Pilewski JM, Celedon JC, Mandalapu S, Blanchard ML, DeRicco A, Hartigan E, Alcorn JF, Kolls JK. Vitamin D supplementation decreases Aspergillus fumigatus specific Th2 responses in CF patients with aspergillus sensitization: a phase one open-label study. Asthma Res Pract. 2015;1:3. doi: 10.1186/s40733-015-0003-5. Epub 2015 Jun 4.

  PMID: 27011794 DERIVED

Related Links

• Vitamin D supplementation decreases Aspergillus fumigatus specific Th2 responses in CF patients with aspergillus sensitization: a phase one open-label study

MeSH Terms

Conditions

Cystic Fibrosis; Aspergillosis, Allergic Bronchopulmonary

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; 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: Joseph M. Pilewski, MD
• Organization: Children's Hospital of Pittsburgh of UPMC

pilewskijm@upmc.edu

(412) 692-2164

Study Officials

• Joseph M Pilewski, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Jay K Kolls, MD

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 29, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)