Status:
COMPLETED
Iron Bioavailability of Fortified Oat Drink
Lead Sponsor:
PepsiCo Global R&D
Collaborating Sponsors:
Food and Nutrition Research Institute, Philippines
Conditions:
Iron Absorption
Eligibility:
All Genders
6-6 years
Phase:
PHASE4
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 drink...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01423162
Start Date
August 1 2011
End Date
September 1 2011
Last Update
September 21 2012
Active Locations (1)
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1
Food and Nutrition Research Institute
City of Taguig, Philippines