Status:
COMPLETED
Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
Lead Sponsor:
Seca GmbH & Co. Kg.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Brief Summary
The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI and FFMI is based on the results of two other clinical investigations: "Generation of prediction equation ...
Eligibility Criteria
Inclusion
- The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited. All subjects need to be suitable for blood donation according to "Hämotherapie-Richtlinie nach §§ 12a und 18 TFG", chapter 2.1.4 "Untersuchung zur Eignung als Spender und zur Feststellung der Spendertauglichkeit".
Exclusion
- amputation of limbs
- electrical implant as cardiac pacemaker
- insulin pumps
- probands who cannot provide an ICF by themselves
- probands who might be dependent from the sponsor or the inv. site
- extensive tattoos at arms or legs
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
992 Patients enrolled
Trial Details
Trial ID
NCT01481285
Start Date
October 1 2011
End Date
January 1 2012
Last Update
October 4 2012
Active Locations (1)
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1
Institute for Transfusion Medicine
Hamburg, Hamburg, Germany, 20246