Evaluation of Fe Absorption From Iron Salt in Milk

Study Overview
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Brief Summary
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The primary objective was: to compare iron absorption in apparently healthy children aged 3-6y from an instant full cream milk drink fortified with ferric pyrophosphate or ferric ammonium phosphate relative to ferrous sulfate as the reference fortificant. To compare iron absorption from ferric pyrophosphate to ferric ammonium phosphate from the milk drink

Official Title
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Evaluation of Iron Absorption From Ferric Ammonium Phosphate and Ferric Pyrophosphate From an Instant Milk Drink in Young Children

Conditions
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Healthy

Intervention / Treatment
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* Other: Iron fortified milk with iron salt labelled with 58Fe and 57Fe
* Other: Iron fortified milk with iron salt labelled with 58Fe and 57Fe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3-6 years old (inclusive) Normal BMI for age (WHO standard) Apparently healthy, no metabolic or gastrointestinal disorder Non-anemic (WHO cut-off for respective age No medication or vitamin/mineral supplements will be consumed during the study Intake of Vitamin/mineral supplements 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 Having obtained his/her parents or his/her legal representative's informed consent Exclusion Criteria: With known gastrointestinal or metabolic disorder or experiencing significant blood losses over the past 6 months Possible to have medication during the study Currently participating or having participated another clinical trial during the past 3 months prior the beginning of this study Subject who cannot be expected to comply with treatment

Ages Eligible for Study
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Minimum Age: 3 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized crossover study with two parallel arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Comparison of iron absorption from FAP to Ferrous sulfate in milk | Other: Iron fortified milk with iron salt labelled with 58Fe and 57Fe<br>* Oral administration of a serving of iron labelled with stable isotope (2 mg Fe per serving) in 200ml of reconstituted milk once after a overnight fast. The alternate test drink was fed on the following day in the same fashion. The administration was repeated on day 3 and 4.<br>* Other names: Iron fortified milk with ferrous sulfate labelled with 58Fe;|
| Other: 2<br>Comparison of iron absorption from ferric pyrophosphate to Ferrous sulfate in milk | Other: Iron fortified milk with iron salt labelled with 58Fe and 57Fe<br>* Oral administration of a serving of iron labelled with stable isotope (2 mg Fe per serving) in 200ml of reconstituted milk once after a overnight fast. The alternate test drink was fed on the following day in the same fashion. The administration was repeated on day 3 and 4.<br>* Other names: Iron fortified milk with ferric pyrophosphate labelled with 57Fe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of iron absorption from FAP and from ferric pyrophosphate relative to Ferrous sulfate | It is based on calculated amount of 58Fe and 57Fe appearing in the blood. For that the shift of the iron isotope ratios in the blood samples collected 14 days after the last consumption of the last test drink are measured. The calculation of circulating iron is based on blood volume and hemoglobin concentration. For calculations of fractional absorption, 90% incorporation of the absorbed iron into red blood cells is assumed. The relative iron absorption from FAP and from ferric pyrophosphate relative to ferrous sulfate is then calculated as follows: Relative bioavailability of a salt (RBV %) = ( Fe absorption from an iron salt/ Fe absorption from ferrous sulfate)∗ 100. The comparison of the iron absorption from ferric pyrophosphate to that from ferric ammonium phosphate will be made by statistical analysis of data measured and calculated as described above. | 14 days post isotope consumption |