Evaluation of Fe Absorption From Iron Salt in Milk

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Iron fortified milk with iron salt labelled with 58Fe and 57Fe

• Registration Number: NCT05642689
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Study First Submitted: 2022-03-29
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-08
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Iron fortified milk with iron salt labelled with 58Fe and 57Fe	Comparison of iron absorption from ferric pyrophosphate to Ferrous sulfate in milk
1	Iron fortified milk with iron salt labelled with 58Fe and 57Fe	Comparison of iron absorption from FAP to Ferrous sulfate in milk

Primary Outcome Measures

Name	Time	Method
Determination of iron absorption from FAP and from ferric pyrophosphate relative to Ferrous sulfate	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.