Iron Bioavailability of Fortified Oat Drink

This study has been completed.
Sponsor:
Collaborator:
Food and Nutrition Research Institute, Philippines
Information provided by (Responsible Party):
PepsiCo Global R&D
ClinicalTrials.gov Identifier:
NCT01423162
First received: August 23, 2011
Last updated: August 22, 2012
Last verified: August 2012
Results First Received: August 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Iron Absorption
Interventions: Other: Dietary Intervention (with Vit C then without Vit C)
Other: Dietary Intervention (without Vit C followed by with Vit C)

  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
Recruitment took place in August 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject was excluded prior to group assignment due to illness

Reporting Groups
  Description
Drink With Vit C Then Drink Without Vit C Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
Drink Without Vitamin C Then Drink With Vit C Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.

Participant Flow:   Overall Study
    Drink With Vit C Then Drink Without Vit C     Drink Without Vitamin C Then Drink With Vit C  
STARTED     11     9  
COMPLETED     11 [1]   9 [1]
NOT COMPLETED     0     0  
[1] Crossover design: All subjects (n=20) completed both arms



  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
Drink With Vit C Then Drink Without Vit C Dietary Intervention (with Vitamin C): Fortified oat drink with vitamin C followed by fortified oat drink without Vit C
Drink Without Vit C Then Drink With Vit C Dietary Intervention (without Vitamin C): Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
Total Total of all reporting groups

Baseline Measures
    Drink With Vit C Then Drink Without Vit C     Drink Without Vit C Then Drink With Vit C     Total  
Number of Participants  
[units: participants]
  11     9     20  
Age  
[units: participants]
     
<=18 years     11     9     20  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age, Customized  
[units: years]
Mean ( Full Range )
     
years     6.3  
  ( 6.0 to 6.6 )  
  6.4  
  ( 6.2 to 6.6 )  
  6.3  
  ( 6.0 to 6.6 )  
Gender  
[units: participants]
     
Female     7     5     12  
Male     4     4     8  
Region of Enrollment  
[units: participants]
     
Philippines     11     9     20  



  Outcome Measures

1.  Primary:   Percent Iron Absorption   [ Time Frame: 14 days after administration ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
One of the isotopes was not detected in blood sample of 1 participant, therefore data from this participant was excluded from final per protocol analysis  


Results Point of Contact:  
Name/Title: Trinidad P. Trinidad
Organization: Food and Nutrition Research Institute
phone: 6328372071 ext 2281
e-mail: trinidadtp@yahoo.com.ph


No publications provided


Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT01423162     History of Changes
Other Study ID Numbers: PEP 1009
Study First Received: August 23, 2011
Results First Received: August 22, 2012
Last Updated: August 22, 2012
Health Authority: Philippines: Ethics Committee