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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
History of Changes
  Purpose

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 Intervention 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 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
Official Title: Iron Bioavailability Study Of Fortified Oat Drink

Resource links provided by NLM:

MedlinePlus related topics: Iron Vitamin C
U.S. FDA Resources

Further study details as provided by PepsiCo Global R&D:

Primary Outcome Measures:
  • 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


Enrollment: 21
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 6 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423162

Locations
Philippines
Food and Nutrition Research Institute
Taguig City, Philippines
Sponsors and Collaborators
PepsiCo Global R&D
Food and Nutrition Research Institute, Philippines
Investigators
Principal Investigator: Trinidad P Trinidad, PhD FNRI
  More Information

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

Keywords provided by PepsiCo Global R&D:
Iron absorption
Oats
fortified oat beverages

Additional relevant MeSH terms:
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
 Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013