NCT01426256

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

5.5 years

First QC Date

August 29, 2011

Last Update Submit

July 11, 2017

Conditions

Cystic FibrosisRespiratory Tract Infections

Keywords

vitamin Dcholecalciferolcystic fibrosisrespiratory tract infectionimmunityintervention studiesinflammationdietary supplementsalpha-DefensinsCytokinesmortalitybiological markersBiomedical Research

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (7)

  • inflammation

    12 months

  • mortality as a separate outcome

    12 months

  • re-hospitalization as a separate outcome

    12 months

  • anti-microbial proteins

    12 months

  • Lung function

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Cholecalciferol (Vitamin D3)

EXPERIMENTAL

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

Placebo

NO INTERVENTION

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.

Interventions

CholecalciferolDIETARY_SUPPLEMENT

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

Also known as: Vitamin D
Cholecalciferol (Vitamin D3)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (4)

  • 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.

    PMID: 18284636BACKGROUND

  • 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.

    PMID: 19336509BACKGROUND

  • 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.

    PMID: 19342361BACKGROUND

  • 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.

    PMID: 30793177DERIVED

MeSH Terms

Conditions

Cystic FibrosisRespiratory Tract InfectionsInflammation

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Vin Tangpricha, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 29, 2011

First Posted

August 31, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(5)