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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
Enrollment 9

Recruitment Details Recruitment was conducted July 2007 to August 2008 at the Atlanta VA Medical Center.
Pre-assignment Details Subjects included those with Crohn's disease and healthy controls.
Arm/Group Title Healthy Control Crohn's Disease
Hide Arm/Group Description [Not Specified] Subjects with stable Crohn's disease
Period Title: Overall Study
Started 4 5
Completed 4 5
Not Completed 0 0
Arm/Group Title Healthy Control Crohn's Disease Total
Hide Arm/Group Description [Not Specified] Subjects with stable Crohn's disease Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
5
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
42.40  (5) 35.5  (10) 39.3  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
5
 100.0%
9
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 9 participants
4 5 9
1.Primary Outcome
Title Intestinal Absorption of Calcium
Hide Description [Not Specified]
Time Frame 12 Weeks
Outcome Measure Data Not Reported
2.Primary Outcome
Title Fractional Absorption of Calcium
Hide Description Fractional absorption of calcium (see citation for complete details)
Time Frame 7 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Control Crohn's Disease
Hide Arm/Group Description:
[Not Specified]
Subjects with stable Crohn's disease
Overall Number of Participants Analyzed 4 5
Measure Type: Number
Unit of Measure: Percentage of absorption
71 115
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Control Crohn's Disease
Hide Arm/Group Description [Not Specified] Subjects with stable Crohn's disease
All-Cause Mortality
Healthy Control Crohn's Disease
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Control Crohn's Disease
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Control Crohn's Disease
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
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
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