Development of Method of Fructose Identification in Urine to Detect the Viral Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01638312
First received: January 20, 2012
Last updated: September 3, 2015
Last verified: September 2012
Results First Received: February 10, 2015  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
"HIV Infected Patients" The people had infected HIV
"Healthy Controls" The people didn't have infected HIV

Participant Flow:   Overall Study
    "HIV Infected Patients"     "Healthy Controls"  
STARTED     20     30  
COMPLETED     20     30  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
"HIV Infected Patients" The people had infected HIV
"Healthy Controls" The people didn't have infected HIV
Total Total of all reporting groups

Baseline Measures
    "HIV Infected Patients"     "Healthy Controls"     Total  
Number of Participants  
[units: participants]
  20     30     50  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     30     50  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  33.15  (10.27)     31.87  (9.46)     32.38  (9.71)  
Gender  
[units: participants]
     
Female     1     18     19  
Male     19     12     31  
Region of Enrollment  
[units: participants]
     
Taiwan     20     30     50  



  Outcome Measures

1.  Primary:   Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform   [ Time Frame: Participants provided urine samples once ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: JihJin Tsai, MD
Organization: Kaohsiung Medical University Chung-Ho Memorial Hospital
phone: 886-7-3121101 ext 6358
e-mail: jijits@cc.kmu.edu.tw


No publications provided


Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01638312     History of Changes
Other Study ID Numbers: KMUH-IRB-20110188
Study First Received: January 20, 2012
Results First Received: February 10, 2015
Last Updated: September 3, 2015
Health Authority: Taiwan: Department of Health