Effects of Vitamin D Supplementation on Lung Function in an Acute Pulmonary Exacerbation of Cystic Fibrosis

NCT00788138 | Completed

• 1 other identifier: Inpatient Vitamin D in CF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D insufficiency is common in patients with cystic fibrosis. The investigators study will examine a large dose of vitamin D given to patients who have cystic fibrosis and are admitted to the hospital for a pulmonary exacerbation to determine whether vitamin D can improve clinical outcomes and whether the dose given is correct. The investigators hypothesis is that vitamin D therapy will improve production of anti-microbial peptides and will increase bacterial killing of microorganisms.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Vitamin D; Anti-microbial peptides

Outcome Measures

Primary Outcomes (2)

• Vitamin D status measured by serum 25-hydroxyvitamin D

  3 months

• Antimicrobial peptide levels of LL-37, an endogenous anti-microbial peptide in humans

  3 months

Secondary Outcomes (3)

• Markers of pulmonary function measured by FEV1 % predicted

  3 months

• Length of hospitalization measured in days

  3 months

• Number of days on antibiotic therapy

  3 months

Study Arms (2)

1

EXPERIMENTAL

Vitamin D3 250,000 PO Once

Dietary Supplement: Vitamin D3

2

PLACEBO COMPARATOR

Matching Placebo

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

250,000 IU of vitamin D3

Also known as: Cholecalciferol

1

Placebo DIETARY_SUPPLEMENT

Matching Placebo

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility Criteria
• Study subjects must be patients diagnosed with cystic fibrosis and seen at the Emory University Cystic Fibrosis Center who are admitted to Emory University Hospital for an acute pulmonary exacerbation of cystic fibrosis as determined by their primary cystic fibrosis physician or emergency room physician.
• Study subjects must agree to participate in the study and provide written informed consent.
• Histology: Not applicable.
• Site: Emory University Hospital.
• Stage of Disease: Admission to Emory University Hospital for an acute pulmonary exacerbation of cystic fibrosis as determined by their primary CF physician based on symptoms and clinical evaluation.
• Age: Study subjects must be \> 18 years old.
• Performance Status: Study subjects will be adult cystic fibrosis patients admitted to the hospital for an acute pulmonary exacerbation who are able to tolerate oral medication and to provide written informed consent.
• Informed Consent Requirement: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English. An additional consent form will be provided to subjects who agree to long term storage of their blood, sputum, saliva, and exhaled breath for future use by investigators of this study.

You may not qualify if:

• Age \< 18 years old.
• Inability to tolerate oral medications in the first 48 hours of admission.
• Prior other diseases: Patients with prior disorders potentially affecting vitamin D levels and metabolism of calcium and phosphate will be excluded. We will exclude patient with any known disorders of the endocrine system affecting vitamin D metabolism including: Hyperparathyroidism, known history of nephrolithiasis, any documented malignances, and advanced renal disease.
• Infection: Not applicable.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 10, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 11, 2010

Record last verified: 2010-10

Locations

US (1)