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



Status:Recruiting
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:16 - Any
Updated:4/21/2016
Start Date:October 2011
End Date:April 2017
Contact:Vin Tangpricha, MD, PhD
Email:vin.tangpricha@emory.edu
Phone:(404) 727-7254

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Vitamin D for Enhancing the Immune System in Cystic Fibrosis

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.

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.

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
We found this trial at
5
sites
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Patricia Joseph, MD
Phone: 513-558-2148
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Amit Gaggar, MD, PHD
Phone: 205-638-2940
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Ruth Grossmann, RN, PhD
Phone: 319-384-7546
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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Atlanta, Georgia 30322
Principal Investigator: Vin Tangpricha, MD, PhD
Phone: 404-727-1549
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Atlanta, GA
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Phone: 216-844-8122
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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