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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

August 23, 2011
August 22, 2012
August 2011
September 2011   (final data collection date for primary outcome measure)
Percent Iron Absorption [ Time Frame: 14 days after administration ] [ Designated as safety issue: No ]
Percentage of iron available for absorption from fortified oat drink with and without added vitamin C
Same as current
Complete list of historical versions of study NCT01423162 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Iron Bioavailability of Fortified Oat Drink
Iron Bioavailability Study Of Fortified Oat Drink

This study will follow a double blinded randomized controlled study design to enroll 20 apparently healthy 6 year old children. The children will be fed with two different nutrient fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA). Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for stable isotope measurements and iron absorption will be calculated.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Iron Absorption
  • Other: Dietary Intervention (with Vit C then without Vit C)
    Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C
  • Other: Dietary Intervention (without Vit C followed by with Vit C)
    Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
  • Experimental: Drink with Vit C then drink without Vit C
    Fortified oat drink with vitamin C on day 1 followed by fortified oat drink without vitamin C on day 2
    Intervention: Other: Dietary Intervention (with Vit C then without Vit C)
  • Experimental: Drink without Vit C then drink with Vit C
    Fortified oat drink without vitamin C on day 1 followed by fortified oat drink with vitamin C on day 2
    Intervention: Other: Dietary Intervention (without Vit C followed by with Vit C)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 6 year old children (inclusive)
  • Normal BMI for age (WHO standard: 15.3-15.5 kg)
  • Apparently healthy, no metabolic or gastrointestinal disorder; non-anemic (Hemoglobin values not less than 11.5 mg/dL -WHO cut-off for respective age)
  • No medication or vitamin/mineral supplement will be consumed during the study; intake of vitamin/mineral supplement will be discontinued 2 weeks before the start of the study
  • Parents demonstrate an understanding of the given information and ability to comply with the study procedure
  • Obtained parental or legal representative's informed consent

Exclusion Criteria:

  • Known gastrointestinal or metabolic disorder or experiencing blood losses over the past 6 months;
  • Children taking medication
  • Children who are anemic (Hemoglobin values less than 11.5 mg/dL - WHO cut-off value for this age)
  • Currently participating or having participated in another clinical trial during the past 3 months prior to the beginning of the study
Both
6 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01423162
PEP 1009
No
PepsiCo Global R&D
PepsiCo Global R&D
Food and Nutrition Research Institute, Philippines
Principal Investigator: Trinidad P Trinidad, PhD FNRI
PepsiCo Global R&D
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP