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Vitamin D Supplementation in Crohn's Patients (CTSA)

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ClinicalTrials.gov Identifier: NCT00742781
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : July 1, 2013
Last Update Posted : July 26, 2013
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Inflammatory Bowel Disease
Intervention: Dietary Supplement: Vitamin D

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited form the Pennsylvania State University University Park area and Hershey College of Medicine. The University General Clinical Research Centers on the two campuses were utilized. Recruitment was from 5/2009 to 7/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was an open label feasibility study that used patients as their own controls. All patients were accepted into the study as long as they met the eligibility requirements.

Reporting Groups
  Description
Vitamin D Supplementation No text entered.

Participant Flow:   Overall Study
    Vitamin D Supplementation
STARTED   21 
COMPLETED   18 
NOT COMPLETED   3 
Withdrawal by Subject                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vitamin D Supplementation No text entered.

Baseline Measures
   Vitamin D Supplementation 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   21 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 38  (17) 
Gender 
[Units: Participants]
 
Female   13 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   21 


  Outcome Measures

1.  Primary:   Crohn's Disease Activity Index   [ Time Frame: 6 months ]

2.  Primary:   25(OH)D3 Serum Levels   [ Time Frame: 6 months ]

3.  Secondary:   Health Improvement   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The main limitation of the study was the lack of placebo control and the small size of the study.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Margherita Cantorna
Organization: Pennsylvania State University
phone: 814-863-2819
e-mail: mxc69@psu.edu



Responsible Party: Margherita T. Cantorna, Penn State University
ClinicalTrials.gov Identifier: NCT00742781     History of Changes
Other Study ID Numbers: CTSA-PPA-1
First Submitted: August 26, 2008
First Posted: August 28, 2008
Results First Submitted: January 23, 2013
Results First Posted: July 1, 2013
Last Update Posted: July 26, 2013