Measurements of Body Iron Excretion of Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00755105
First received: September 16, 2008
Last updated: August 4, 2011
Last verified: August 2011
Results First Received: December 30, 2008  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Healthy

  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
Participants were invited to join the study if they had participated in a study involving consumption of Iron-55 at least one year earlier at Grand Forks Human Nutrition Research Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants were included

Reporting Groups
  Description
Male Subjects Having Consumed Iron-55 Tracer No text entered.
Menstruating Women Having Consumed Iron-55 Tracer Includes women on hormonal contraceptives
Postmenopausal Women Having Consumed Iron-55 Tracer No text entered.

Participant Flow:   Overall Study
    Male Subjects Having Consumed Iron-55 Tracer     Menstruating Women Having Consumed Iron-55 Tracer     Postmenopausal Women Having Consumed Iron-55 Tracer  
STARTED     38     30     9  
COMPLETED     29     19     5  
NOT COMPLETED     9     11     4  
Withdrawal by Subject                 9                 11                 4  



  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.
No text entered.

Reporting Groups
  Description
Male Subjects Having Consumed Iron-55 Tracer No text entered.
Menstruating Women Having Consumed Iron-55 Tracer Includes women on hormonal contraceptives
Postmenopausal Women Having Consumed Iron-55 Tracer No text entered.
Total Total of all reporting groups

Baseline Measures
    Male Subjects Having Consumed Iron-55 Tracer     Menstruating Women Having Consumed Iron-55 Tracer     Postmenopausal Women Having Consumed Iron-55 Tracer     Total  
Number of Participants  
[units: participants]
  38     30     9     77  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 8     40  ± 5     50  ± 5     43  ± 7  
Gender  
[units: participants]
       
Female     0     30     9     39  
Male     38     0     0     38  



  Outcome Measures

1.  Primary:   Rate of Iron Excretion.   [ Time Frame: 4 years ]


  Serious Adverse Events


  Other Adverse Events


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


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.  


Results Point of Contact:  
Name/Title: Janet Hunt, PhD
Organization: USDA Grand Forks Human Nutrition Research Center
phone: 701-795-8353
e-mail: janetrhunt@gmail.com


No publications provided by USDA Grand Forks Human Nutrition Research Center

Publications automatically indexed to this study:

Responsible Party: Janet R Hunt, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00755105     History of Changes
Other Study ID Numbers: GFHNRC049
Study First Received: September 16, 2008
Results First Received: December 30, 2008
Last Updated: August 4, 2011
Health Authority: United States: Federal Government