Iron Bioavailability From MyPyramid Menus

This study has been completed.
Sponsor:
Information provided by:
USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00754234
First received: September 16, 2008
Last updated: June 1, 2011
Last verified: June 2011
Results First Received: December 30, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Crossover Assignment;   Masking: 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


  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: Brenda Ling
Organization: United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
phone: 701-795-8300
e-mail: brenda.ling@ars.usda.gov


No publications provided


Responsible Party: Janet R Hunt, Ph.D., R.D. Research Nutritionist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00754234     History of Changes
Other Study ID Numbers: GFHNRC003
Study First Received: September 16, 2008
Results First Received: December 30, 2008
Last Updated: June 1, 2011
Health Authority: United States: Federal Government