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Iron Bioavailability of Fortified Oat Drink

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ClinicalTrials.gov Identifier: NCT01423162
Recruitment Status : Completed
First Posted : August 25, 2011
Results First Posted : September 21, 2012
Last Update Posted : September 21, 2012
Sponsor:
Collaborator:
Food and Nutrition Research Institute, Philippines
Information provided by (Responsible Party):
PepsiCo Global R&D

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Iron Absorption Other: Dietary Intervention (with Vit C then without Vit C) Other: Dietary Intervention (without Vit C followed by with Vit C) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Iron Bioavailability Study Of Fortified Oat Drink
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arms and Interventions
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Arm Intervention/treatment
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
 Other: Dietary Intervention (with Vit C then without Vit C)
Fortified oat drink with vitamin C followed by fortified oat drink without vitamin 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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Percent Iron Absorption [ Time Frame: 14 days after administration ]
    Percentage of iron available for absorption from fortified oat drink with and without added vitamin C


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423162


Locations
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Philippines
Food and Nutrition Research Institute
Taguig City, Philippines
Sponsors and Collaborators
PepsiCo Global R&D
Food and Nutrition Research Institute, Philippines
Investigators
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Principal Investigator: Trinidad P Trinidad, PhD FNRI
More Information
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT01423162    
Other Study ID Numbers: PEP 1009
First Posted: August 25, 2011    Key Record Dates
Results First Posted: September 21, 2012
Last Update Posted: September 21, 2012
Last Verified: August 2012
Keywords provided by PepsiCo Global R&D:
Iron absorption
Oats
fortified oat beverages
Additional relevant MeSH terms:
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Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Vitamins
Micronutrients