Improving Vitamin D Status In Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT00450073
First received: March 19, 2007
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to establish an effective method to correct vitamin D deficiency in subjects with cystic fibrosis. The investigators will examine cholecalciferol, ergocalciferol and UV light.


Condition Intervention
Cystic Fibrosis
Drug: ergocalciferol (vitamin D2)
Device: Sperti Del Sol Lamp
Drug: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Desktop Tanning Unit to Improve Vitamin D Status in Patients With Cystic Fibrosis and Short Bowel Syndrome: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Atlanta VA Medical Center:

Primary Outcome Measures:
  • 25-hydroxyvitamin D [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    This is a marker of vitamin D status


Secondary Outcome Measures:
  • Parathyroid Hormone, Serum C-telopeptide, Osteocalcin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D3
Vitamin D3=cholecalciferol 50,000 IU weekly
Drug: Vitamin D3
50,000 IU weekly
Other Name: D3
Active Comparator: vitamin D2
The intervention is an oral tablet of vitamin D2 (ergocaliferol 50,000 IU weekly) for 12 weeks.
Drug: ergocalciferol (vitamin D2)
50,000 IU weekly
Other Name: D2
Active Comparator: Sunlamp
The intervention is the use of a Sunlamp (Sperti) to the skin 5 times a week for 12 weeks
Device: Sperti Del Sol Lamp
5 times a week for 12 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects seen initially at the Emory CF center between the months of September and December
  • Age > 16, both males and females, confirmed cystic fibrosis by genetic testing or sweat testing, FEV1 > 40%.

Exclusion Criteria:

  • History of lung transplant or awaiting lung transplantation
  • Current hospitalization or greater than 6 hospitalizations/year
  • History of malignancy, renal disease (calculated GFR < 50% reduced from normal), liver disease (AST or AST > 3 times upper limit of normal), greater than 10 mg of prednisone or equivalent, hypercalcemia
  • History of easily burned skin after sunlight exposure, taking medications with may cause photosensitivity
  • History of skin cancer or multiple moles or family history of skin cancer
  • Moderate to severe vitamin D deficiency (25(OH)D ≤ 15 ng/ml).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450073

Locations
United States, Georgia
Emory CF Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Atlanta VA Medical Center
Emory University
Investigators
Principal Investigator: Vin Tangpricha, M.D. Ph.D. Emory University
  More Information

Publications:
Responsible Party: Vin Tangpricha, Associate Professor, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00450073     History of Changes
Other Study ID Numbers: Cystic Fibrosis Vitamin D
Study First Received: March 19, 2007
Results First Received: January 28, 2013
Last Updated: January 7, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Short Bowel Syndrome
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Postoperative Complications
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014