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Trial record 1 of 1 for:    20306476 [PUBMED-IDS]
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Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption

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ClinicalTrials.gov Identifier: NCT00427804
Recruitment Status : Completed
First Posted : January 29, 2007
Results First Posted : September 2, 2011
Last Update Posted : February 4, 2013
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Rheumatoid Arthritis
Crohn's Disease
Intervention: Drug: calcitriol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was conducted July 2007 to August 2008 at the Atlanta VA Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects included those with Crohn's disease and healthy controls.

Reporting Groups
  Description
Healthy Control No text entered.
Crohn's Disease Subjects with stable Crohn's disease

Participant Flow:   Overall Study
    Healthy Control   Crohn's Disease
STARTED   4   5 
COMPLETED   4   5 
NOT COMPLETED   0   0 



  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
Healthy Control No text entered.
Crohn's Disease Subjects with stable Crohn's disease
Total Total of all reporting groups

Baseline Measures
   Healthy Control   Crohn's Disease   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   5   9 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   4   5   9 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.40  (5)   35.5  (10)   39.3  (8) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   4   5   9 
Region of Enrollment 
[Units: Participants]
     
United States   4   5   9 


  Outcome Measures

1.  Primary:   Fractional Absorption of Calcium   [ Time Frame: 7 week ]

2.  Primary:   Intestinal Absorption of Calcium   [ Time Frame: 12 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vin Tangpricha, M.D., Ph.D.
Organization: Emory University
phone: 404-727-7254
e-mail: vin.tangpricha@emory.edu


Publications of Results:

Responsible Party: Vin Tangpricha, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00427804     History of Changes
Other Study ID Numbers: Vitamin D-2007
First Submitted: January 25, 2007
First Posted: January 29, 2007
Results First Submitted: August 3, 2011
Results First Posted: September 2, 2011
Last Update Posted: February 4, 2013