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Completed

NCT Number: NCT01423162

Iron Bioavailability 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.

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Key information

Conditions

Iron Absorption

Age range

6 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Food and Nutrition Research Institute

City of Taguig, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention (with Vit C then without Vit C)

Other

Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C

Dietary Intervention (without Vit C followed by with Vit C)

Other

Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Collaborators

  • Food and Nutrition Research Institute, Philippines

Registry information

Official study title

Iron Bioavailability Study Of Fortified Oat Drink

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 25, 2011
Registry last updated
Sep 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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