Evaluation of Fe Absorption From Iron Salt in Milk

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Iron fortified milk with iron salt labelled with 58Fe and 57Fe

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Comparison of iron absorption from FAP to Ferrous sulfate in milk	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.; Other Names: Iron fortified milk with ferrous sulfate labelled with 58Fe; Iron fortified milk with ferric pyrophosphate labelled with 57Fe
Other: 2; Comparison of iron absorption from ferric pyrophosphate to Ferrous sulfate in milk	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.; Other Names: Iron fortified milk with ferrous sulfate labelled with 58Fe; Iron fortified milk with ferric pyrophosphate labelled with 57Fe

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nestlé
• Collaborators: Food and Nutrition Research Institute, Philippines; ETH Zurich (Switzerland)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Estimate): December 8, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: 09.07NRC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No