Iron Bioavailability of Fortified Oat Drink

Iron Absorption Clinical Trial

Official title:

Iron Bioavailability Study Of Fortified Oat Drink

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423162
• Other study ID #: PEP 1009
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2011
• Last updated: August 22, 2012
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: August 2012
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 6 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Iron Absorption

Intervention

Other:
• Dietary Intervention (with Vit C then without Vit C)
Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C
• Dietary Intervention (without Vit C followed by with Vit C)
Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C

Locations

Country	Name	City	State
Philippines	Food and Nutrition Research Institute	Taguig City

Sponsors (2)

Lead Sponsor	Collaborator
PepsiCo Global R&D	Food and Nutrition Research Institute, Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Iron Absorption	Percentage of iron available for absorption from fortified oat drink with and without added vitamin C	14 days after administration	No