Evaluation of Fe Absorption From Iron Salt in Milk

NCT05642689 | Completed

• 1 other identifier: 09.07NRC
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

OTHER

Comparison of iron absorption from FAP to Ferrous sulfate in milk

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

2

OTHER

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

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

Interventions

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.

Also known as: Iron fortified milk with ferrous ammonium posphate labelled with 57Fe, Iron fortified milk with ferrous sulfate labelled with 58Fe

1

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• ETH Zurich (Switzerland): collaborator
• Food and Nutrition Research Institute, Philippines: collaborator

Related Publications (1)

• 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.

  PMID: 22956195 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind randomized crossover study with two parallel arms

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: December 8, 2022
• Study Start: November 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 14, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share