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Iron Bioavailability From MyPyramid Menus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754234
First Posted: September 17, 2008
Last Update Posted: June 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
USDA Grand Forks Human Nutrition Research Center
Results First Submitted: December 30, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Nonheme Iron Absorption
Intervention: Behavioral: My Pyramid menu days 1, 2, 3, 4, 5, 6 or 7

  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 recruited from the Grand Forks, North Dakota community in September 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
154 applied,(47 applied too late, 30 did not meet inclusion criteria and 52 refused participation) 25 screened,4 excluded (3 did not pass screen and 1 refused participation), 5 alternates

Reporting Groups
  Description
MyPyramid Menus USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

Participant Flow:   Overall Study
    MyPyramid Menus
STARTED   16 [1] 
COMPLETED   13 [2] 
NOT COMPLETED   3 
Withdrawal by Subject                3 
[1] 7 Menus were consumed in randomized order
[2] 2 participants did not receive the Day 1,4,5,6 menu and 1 did not receive the Day 2 menu



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Nonheme Iron Absorption   [ Time Frame: 2 weeks (wks) ]


  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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