Evaluation of Fe Absorption From Iron Salt in Milk

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

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Key information

Conditions

Healthy

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Iron fortified milk with iron salt labelled with 58Fe and 57Fe

Other

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.

Other names: Iron fortified milk with ferrous ammonium posphate labelled with 57Fe, Iron fortified milk with ferrous sulfate labelled with 58Fe

Primary outcomes

Determination of iron absorption from FAP and from ferric pyrophosphate relative to Ferrous sulfate

Time frame: 14 days post isotope consumption

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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

ETH Zurich (Switzerland)
Food and Nutrition Research Institute, Philippines

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 8, 2022
Registry last updated: May 14, 2025

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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Completed