Iron Bioavailability of Fortified Oat Drink

Study Overview
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Brief Summary
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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.

Official Title
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Iron Bioavailability Study Of Fortified Oat Drink

Conditions
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Iron Absorption

Intervention / Treatment
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* Other: Dietary Intervention (with Vit C then without Vit C)
* Other: Dietary Intervention (without Vit C followed by with Vit C)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drink with Vit C then drink without Vit C<br>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)<br>* Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C<br>|
| Experimental: Drink without Vit C then drink with Vit C<br>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)<br>* Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Iron Absorption | Percentage of iron available for absorption from fortified oat drink with and without added vitamin C | 14 days after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron absorption, Oats, fortified oat beverages