Evaluation of Fe Absorption From Iron Salt in Milk

NCT ID: NCT05642689

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-03-31

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomized crossover study with two parallel arms
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Comparison of iron absorption from FAP to Ferrous sulfate in milk

Group Type OTHER

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

Intervention Type 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.

2

Comparison of iron absorption from ferric pyrophosphate to Ferrous sulfate in milk

Group Type OTHER

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

Intervention Type 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.

Interventions

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

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.

Intervention Type OTHER

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

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.

Intervention Type OTHER

Other Intervention Names

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Iron fortified milk with ferrous ammonium posphate labelled with 57Fe Iron fortified milk with ferrous sulfate labelled with 58Fe Iron fortified milk with ferrous sulfate labelled with 58Fe Iron fortified milk with ferric pyrophosphate labelled with 57Fe

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ETH Zurich (Switzerland)

OTHER

Sponsor Role collaborator

Food and Nutrition Research Institute, Philippines

OTHER_GOV

Sponsor Role collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Walczyk T, Kastenmayer P, Storcksdieck Genannt Bonsmann S, Zeder C, Grathwohl D, Hurrell RF. Ferrous ammonium phosphate (FeNH(4)PO(4)) as a new food fortificant: iron bioavailability compared to ferrous sulfate and ferric pyrophosphate from an instant milk drink. Eur J Nutr. 2013 Jun;52(4):1361-8. doi: 10.1007/s00394-012-0445-y. Epub 2012 Sep 6.

Reference Type BACKGROUND
PMID: 22956195 (View on PubMed)

Other Identifiers

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09.07NRC

Identifier Type: -

Identifier Source: org_study_id

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