We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Vitamin D Status In Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00450073
Recruitment Status : Completed
First Posted : March 21, 2007
Results First Posted : February 21, 2014
Last Update Posted : February 21, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cystic Fibrosis Drug: ergocalciferol (vitamin D2) Device: Sperti Del Sol Lamp Drug: Vitamin D3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2006
Primary Completion Date : May 2011
Study Completion Date : May 2011


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 25-hydroxyvitamin D [ Time Frame: 12 weeks ]
    This is a marker of vitamin D status


Secondary Outcome Measures :
  1. Parathyroid Hormone, Serum C-telopeptide, Osteocalcin [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 21, 2007    Key Record Dates
Results First Posted: February 21, 2014
Last Update Posted: February 21, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents