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Cystic FibrosisPhase 3DISCNCT01426256

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

A Phase 3 study testing Cholecalciferol in people with Cystic Fibrosis and Respiratory Tract Infections, run by Emory University at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Cystic Fibrosis, Respiratory Tract Infections
What is being tested?
Cholecalciferol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
5 sitesUnited States
Study dates
Oct 2011to Jul 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 21Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory Hospital

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Cholecalciferol
Keywords
vitamin D, cholecalciferol, cystic fibrosis, respiratory tract infection, immunity, intervention studies, inflammation, dietary supplements, alpha-Defensins, Cytokines, mortality, biological markers, Biomedical Research
Medical subject headings
Cystic Fibrosis, Respiratory Tract Infections, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CholecalciferolDietary supplement

    Also called Vitamin D

    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

Study groups in NCT01426256
Study groupRoleWhat they receive
Cholecalciferol (Vitamin D3)ExperimentalPatients 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.
Receives: Dietary Supplement: Cholecalciferol
PlaceboNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study enrollment to next pulmonary exacerbation requiring any antibiotics, hospitalization or death.

    Measured: 12 months

Secondary outcomes (7)

  1. inflammation

    We will examine whether the high-dose vitamin D treatment regimen decreases the pro-inflammatory cytokines, IL-6, IL-8, and TNF- α.

    Measured: 12 months

  2. mortality as a separate outcome

    Measured: 12 months

  3. re-hospitalization as a separate outcome

    Measured: 12 months

  4. anti-microbial proteins

    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).

    Measured: 12 months

  5. Lung function

    We will examine whether high dose vitamin D improves serial lung function, as measured by FEV1

    Measured: 12 months

  6. Antibiotic use

    Rates of pulmonary exacerbation requiring antibiotics due to presumed infection after 12 month

    Measured: 12 months

  7. glucose metabolism

    Rates of new onset diabetes and mean glucose values in each group

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionApr 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01426256
Sponsor's protocol ID
IRB00052829
Other IDs
TANGOR11A0
Acronym
DISC
Status last verified
Jul 2017
First submitted
29 Aug 2011
Last updated
13 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Wolfenden LL, Judd SE, Shah R, Sanyal R, Ziegler TR, Tangpricha V. Vitamin D and bone health in adults with cystic fibrosis. Clin Endocrinol (Oxf). 2008 Sep;69(3):374-81. doi: 10.1111/j.1365-2265.2008.03216.x. Epub 2008 Feb 11.

    PubMed 18284636

  • Khazai NB, Judd SE, Jeng L, Wolfenden LL, Stecenko A, Ziegler TR, Tangpricha V. Treatment and prevention of vitamin D insufficiency in cystic fibrosis patients: comparative efficacy of ergocalciferol, cholecalciferol, and UV light. J Clin Endocrinol Metab. 2009 Jun;94(6):2037-43. doi: 10.1210/jc.2008-2012. Epub 2009 Mar 31.

    PubMed 19336509

  • Pepper KJ, Judd SE, Nanes MS, Tangpricha V. Evaluation of vitamin D repletion regimens to correct vitamin D status in adults. Endocr Pract. 2009 Mar;15(2):95-103. doi: 10.4158/EP.15.2.95.

    PubMed 19342361

  • Tangpricha V, Lukemire J, Chen Y, Binongo JNG, Judd SE, Michalski ES, Lee MJ, Walker S, Ziegler TR, Tirouvanziam R, Zughaier SM, Chesdachai S, Hermes WA, Chmiel JF, Grossmann RE, Gaggar A, Joseph PM, Alvarez JA. Vitamin D for the Immune System in Cystic Fibrosis (DISC): a double-blind, multicenter, randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2019 Mar 1;109(3):544-553. doi: 10.1093/ajcn/nqy291.

    PubMed 30793177

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cholecalciferol in people with Cystic Fibrosis and Respiratory Tract Infections, run by Emory University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study enrollment to next pulmonary exacerbation requiring any antibiotics, hospitalization or death. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01426256, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.

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