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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01426256
• Date of registration: 29/08/2011
• Prospective Registration: Yes
• Primary sponsor: Emory University
• Public title: Vitamin D for Enhancing the Immune System in Cystic Fibrosis (DISC Study) DISC
• Scientific title: Vitamin D for Enhancing the Immune System in Cystic Fibrosis
• Date of first enrolment: October 2011
• Target sample size: 91
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01426256
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Vin Tangpricha, MD, PhD
• Affiliation: Emory University

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Respiratory Tract Infections

Intervention(s)

Dietary Supplement: Cholecalciferol

Primary Outcome(s)

Study enrollment to next pulmonary exacerbation requiring any antibiotics, hospitalization or death. [Time Frame: 12 months]

Secondary Outcome(s)

inflammation [Time Frame: 12 months]

glucose metabolism [Time Frame: 12 months]

Lung function [Time Frame: 12 months]

re-hospitalization as a separate outcome [Time Frame: 12 months]

Antibiotic use [Time Frame: 12 months]

mortality as a separate outcome [Time Frame: 12 months]

anti-microbial proteins [Time Frame: 12 months]

Secondary ID(s)

TANGOR11A0

IRB00052829

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation Therapeutics