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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
History of Changes
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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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 ]
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Measure Type Primary
Measure Title Rate of Iron Excretion.
Measure Description Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55
Time Frame 4 years  
Safety Issue No  

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.
Per protocol

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.

Measured Values
    Male Subjects Having Consumed Iron-55 Tracer     Menstruating Women Having Consumed Iron-55 Tracer     Postmenopausal Women Having Consumed Iron-55 Tracer  
Number of Participants Analyzed  
[units: participants]
 		  29     19     5  
Rate of Iron Excretion.  
[units: milligrams per day]
Mean ( 95% Confidence Interval ) 		  1.07  
  ( 0.89 to 1.25 )   		  1.69  
  ( 1.30 to 2.20 )   		  1.08  
  ( 0.73 to 1.43 )  


Statistical Analysis 1 for Rate of Iron Excretion.
Groups [1] All groups
Method [2] ANOVA
P Value [3] < 0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events
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  Other Adverse Events
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  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