Trial Outcomes & Findings for Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption (NCT NCT00427804)

NCT ID: NCT00427804

Last Updated: 2013-02-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 12 Weeks
• Results posted on: 2013-02-04

Participant Flow

Recruitment was conducted July 2007 to August 2008 at the Atlanta VA Medical Center.

Subjects included those with Crohn's disease and healthy controls.

Participant milestones

Measure	Healthy Control	Crohn's Disease Subjects with stable Crohn's disease
Overall Study STARTED	4	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption

Baseline characteristics by cohort

Measure	Healthy Control n=4 Participants	Crohn's Disease n=5 Participants Subjects with stable Crohn's disease	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	42.40 years STANDARD_DEVIATION 5 • n=5 Participants	35.5 years STANDARD_DEVIATION 10 • n=7 Participants	39.3 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 7 week

Fractional absorption of calcium (see citation for complete details)

Outcome measures

Measure	Healthy Control n=4 Participants	Crohn's Disease n=5 Participants Subjects with stable Crohn's disease
Fractional Absorption of Calcium	71 Percentage of absorption	115 Percentage of absorption

Adverse Events

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crohn's Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vin Tangpricha, M.D., Ph.D.

Emory University

Phone: 404-727-7254

Email: vin.tangpricha@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place