NCT00450073

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 21, 2014

Completed
Last Updated

February 21, 2014

Status Verified

January 1, 2014

Enrollment Period

4.5 years

First QC Date

March 19, 2007

Results QC Date

January 28, 2013

Last Update Submit

January 7, 2014

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 25-hydroxyvitamin D

    This is a marker of vitamin D status

    12 weeks

Secondary Outcomes (1)

  • Parathyroid Hormone, Serum C-telopeptide, Osteocalcin

    12 weeks

Study Arms (3)

Vitamin D3

ACTIVE COMPARATOR

Vitamin D3=cholecalciferol 50,000 IU weekly

Drug: Vitamin D3

vitamin D2

ACTIVE COMPARATOR

The intervention is an oral tablet of vitamin D2 (ergocaliferol 50,000 IU weekly) for 12 weeks.

Drug: ergocalciferol (vitamin D2)

Sunlamp

ACTIVE COMPARATOR

The intervention is the use of a Sunlamp (Sperti) to the skin 5 times a week for 12 weeks

Device: Sperti Del Sol Lamp

Interventions

ergocalciferol (vitamin D2)DRUG

50,000 IU weekly

Also known as: D2
vitamin D2
Sperti Del Sol LampDEVICE

5 times a week for 12 weeks

Sunlamp
Vitamin D3DRUG

50,000 IU weekly

Also known as: D3
Vitamin D3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory CF Center

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

  • Grossmann RE, Zughaier SM, Liu S, Lyles RH, Tangpricha V. Impact of vitamin D supplementation on markers of inflammation in adults with cystic fibrosis hospitalized for a pulmonary exacerbation. Eur J Clin Nutr. 2012 Sep;66(9):1072-4. doi: 10.1038/ejcn.2012.82. Epub 2012 Jul 18.

    PMID: 22805498RESULT

  • Grossmann RE, Zughaier SM, Kumari M, Seydafkan S, Lyles RH, Liu S, Sueblinvong V, Schechter MS, Stecenko AA, Ziegler TR, Tangpricha V. Pilot study of vitamin D supplementation in adults with cystic fibrosis pulmonary exacerbation: A randomized, controlled trial. Dermatoendocrinol. 2012 Apr 1;4(2):191-7. doi: 10.4161/derm.20332.

    PMID: 22928076RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

ErgocalciferolsCholecalciferol

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Vin Tangpricha
Organization
Emory University
vin.tangpricha@emory.edu
4047277254

Study Officials

  • Vin Tangpricha, M.D. Ph.D.

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 21, 2007

Study Start

November 1, 2006

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

February 21, 2014

Results First Posted

February 21, 2014

Record last verified: 2014-01

Locations

US(1)