Vitamin D for Enhancing the Immune System in Cystic Fibrosis (DISC Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Vin Tangpricha, MD, PH.D, Emory University
ClinicalTrials.gov Identifier:
NCT01426256
First received: August 29, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The purpose of this study is determine if high-dose vitamin D supplementation improves clinical outcomes related to lung function and immunity in patients with Cystic Fibrosis who are admitted to the hospital with an acute lung infection.


Condition Intervention Phase
Cystic Fibrosis
Respiratory Tract Infections
Dietary Supplement: Cholecalciferol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D for Enhancing the Immune System in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The composite measure of deaths and re-hospitalizations after randomization [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • inflammation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will examine whether the high-dose vitamin D treatment regimen decreases the pro-inflammatory cytokines, IL-6, IL-8, and TNF- α.

  • mortality as a separate outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • re-hospitalization as a separate outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • anti-microbial proteins [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will examine whether the high-dose vitamin D treatment regimen increases cathelicidin and hBD-2 mRNA expression in both peripheral blood mononuclear cells (PBMCs) and induced sputum (by quantitative PCR).

  • Lung function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will examine whether high dose vitamin D improves serial lung function, as measured by FEV1

  • Antibiotic use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Rates of pulmonary exacerbation requiring antibiotics due to presumed infection after 12 month


Estimated Enrollment: 280
Study Start Date: October 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholecalciferol (Vitamin D3)
Patients will be given 250,000 IU cholecalciferol in one bolus oral dose while they are in the hospital. Three months after the initial bolus dose, patients will take 50,000 IU oral cholecalciferol every other week for 9 months.
Dietary Supplement: Cholecalciferol
Bolus dose of 250,000 IU during hospitalization + maintenance dose of 50,000 IU vitamin D every other week to be initiated 3 months after bolus dose
Other Name: Vitamin D
No Intervention: Placebo
Patients will be given placebo pills in one bolus oral dose while they are in the hospital. Three months after the initial bolus dose, patients will take a placebo pill every other week for 9 months.

Detailed Description:

Patients with Cystic Fibrosis (CF) have a shorter life span than the general population due to complications with lung infections, which eventually progress to lung failure. New research has suggested that high levels of vitamin D may be protective against lung infections and may promote the action of anti-bacterial proteins needed to ward off infections. Research has also suggested that high vitamin D levels are linked to lower mortality rates; however these hypotheses have not been adequately studied in patients with CF. An investigation of the effects of vitamin D supplementation is of particular interest in this population because patients with CF generally have high rates of vitamin D deficiency. The investigators have preliminary data from a previous study suggesting that vitamin D supplementation in patients with CF lowers markers of inflammation, promotes anti-bacterial proteins, and reduces mortality. In this proposed multi-center study the investigators will examine the effects of a high dose vitamin D supplementation on patients with CF who are admitted to the hospital for lung infection. The investigators will use a randomized, placebo-controlled trial design to determine if mortality and infection rates over 1 year are reduced in patients who receive the high-dose vitamin D supplementation compared to those who receive placebo. The investigators will also determine if vitamin D affects markers of inflammation and anti-bacterial proteins, as well as CF-related clinical outcomes, such as lung function. The investigators plan to recruit 280 adults and adolescents with CF (ages > 16yrs), with approximately 150 subjects recruited at Emory (Emory University Hospital and Children's Healthcare of Atlanta). Participants will initially be seen by the study researchers during the first week of in-patient hospitalization, and they will be followed over the course of one year during their regularly-scheduled out-patient CF clinic visits. The treatment group will receive an initial oral bolus dose of 250,000 IU vitamin D, and at 3 months follow-up they will receive 50,000 IU vitamin D every other week. Current CF Guidelines for vitamin D supplementation recommend a daily intake of 800 IU of vitamin D per day, therefore in addition to the vitamin D or placebo they receive at the beginning of the study and at 3 months, all participants will receive 800 IU of vitamin D daily. If our hypotheses are correct, this study has potential for reducing infection and promoting survival in patients with CF using vitamin D, a relatively inexpensive supplement.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult and adolescent CF patients
  • age >16 years
  • admitted to the inpatient hospital setting for a pulmonary exacerbation of cystic fibrosis
  • enrolled within 72 hours of admission
  • able to tolerate oral medications
  • expected to survive hospitalization

Exclusion Criteria:

  • Inability to obtain or declined informed consent from the subject and/or legally authorized representative
  • History of serum 25(OH)D >55 ng/mL in the past 12 months
  • History of serum 25(OH)D <10 ng/mL in the past 12 months
  • Current intake of more than 2,000 IU of vitamin D
  • intake of 2,000 IU of vitamin D or its equivalent weekly dose (14,000 IU) for more than 1 week at any time within the past 60 days or intake of greater than vitamin D 10,000 IU once at anytime in the past 60 days
  • Pregnancy or plans to become pregnant during the course of the study (12 months)
  • History of disorders associated with hypercalcemia including parathyroid disease
  • Current hypercalcemia (albumin-corrected serum calcium >10.8 mg/dL or ionized calcium >5.2 mg/dL)
  • History of nephrolithiasis
  • Chronic kidney disease worse than stage III (<60 ml/min)
  • Oral or intravenous glucocorticoid use currently or in the past month
  • History of lung transplantation or awaiting lung transplant
  • patient in hospice care
  • FEV1% predicted <20%
  • Current significant hepatic dysfunction total bilirubin > 2.5 mg/dL with direct bilirubin > 1.0 mg/dL
  • Current use of cytotoxic or immunosuppressive drugs
  • History of AIDS
  • History of illicit drug abuse (defined as history of enrollment into a drug rehabilitation program or hospital visits due to drug use within the past 3 years or any use of the following drugs in the past 6 months (cocaine, opiates, amphetamines, marijuana) or any positive toxicology screen for (cocaine, opiates, amphetamines, marijuana)
  • Previous enrollment in the study
  • Current enrollment in another intervention trial
  • Too ill to participate in study based on investigator's or study team's opinion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426256

Contacts
Contact: Vin Tangpricha, MD, PhD (404) 727-7254 vin.tangpricha@emory.edu
Contact: Jessica A Alvarez, PhD, RD (404) 727-1549 jessica.alvarez@emory.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Sherry Tidwell, RRT, CCRC    205-638-2940    stidwell@uab.edu   
Principal Investigator: Amit Gaggar, MD, PHD         
United States, Georgia
Emory Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jessica A Alvarez, PhD, RD    404-727-1549    jessica.alvarez@emory.edu   
Principal Investigator: Vin Tangpricha, MD, PhD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mary Teresi, PharmD    319-384-7546    mary-teresi@uiowa.edu   
Principal Investigator: Ruth Grossmann, RN, PhD         
United States, Ohio
University of Cincinnati Not yet recruiting
Cincinnati, Ohio, United States, 45267
Contact: Tammy Roads, CCRC    513-558-2148    roadst@ucmail.uc.edu   
Principal Investigator: Patricia Joseph, MD         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Erni Bateman    216-844-8122      
Sub-Investigator: James Chmiel, MD         
Sponsors and Collaborators
Emory University
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Vin Tangpricha, MD, PhD Emory University
  More Information

Publications:
Responsible Party: Vin Tangpricha, MD, PH.D, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT01426256     History of Changes
Other Study ID Numbers: IRB00052829, TANGOR11A0
Study First Received: August 29, 2011
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
vitamin D
cholecalciferol
cystic fibrosis
respiratory tract infection
immunity
intervention studies
inflammation
dietary supplements
alpha-Defensins
Cytokines
mortality
biological markers
Biomedical Research

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Respiratory Tract Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Infection
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 18, 2014