HealthyNCT05642689
Evaluation of Fe Absorption From Iron Salt in Milk
A study testing Iron fortified milk with iron salt labelled with 58Fe and 57Fe in people with Healthy, run by Société des Produits Nestlé (SPN).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Iron fortified milk with iron salt labelled with 58Fe and 57Fe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
- Conditions
- Healthy
- Being tested
- Iron fortified milk with iron salt labelled with 58Fe and 57Fe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron fortified milk with iron salt labelled with 58Fe and 57FeOther
Also called Iron fortified milk with ferrous ammonium posphate labelled with 57Fe, Iron fortified milk with ferrous sulfate labelled with 58Fe
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.
Iron fortified milk with iron salt labelled with 58Fe and 57FeOther
Also called Iron fortified milk with ferrous sulfate labelled with 58Fe, Iron fortified milk with ferric pyrophosphate labelled with 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Comparison of iron absorption from FAP to Ferrous sulfate in milk Receives: 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 Receives: Other: Iron fortified milk with iron salt labelled with 58Fe and 57Fe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days post isotope consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study startNov 2009
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized crossover study with two parallel arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ETH Zurich (Switzerland), Food and Nutrition Research Institute, Philippines
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642689
- Sponsor's protocol ID
- 09.07NRC
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2022
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22956195
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Iron Absorption From Ferric Ammonium Phosphate and Ferric Pyrophosphate From an Instant Milk Drink in Young Children
- ClinicalTrials.gov ID
- NCT05642689
- Acronym / sponsor ID
- 09.07NRC
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- ETH Zurich (Switzerland), Food and Nutrition Research Institute, Philippines
- Study start
- Nov 2009 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind randomized crossover study with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Iron fortified milk with iron salt labelled with 58Fe and 57FeComparison of iron absorption from FAP to Ferrous sulfate in milk |
| 2 | Other | Other: Iron fortified milk with iron salt labelled with 58Fe and 57FeComparison of iron absorption from ferric pyrophosphate to Ferrous sulfate in milk |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron fortified milk with iron salt labelled with 58Fe and 57FeAlso: Iron fortified milk with ferrous ammonium posphate labelled with 57Fe, Iron fortified milk with ferrous sulfate labelled with 58FeOral 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 | 1 |
| Iron fortified milk with iron salt labelled with 58Fe and 57FeAlso: Iron fortified milk with ferrous sulfate labelled with 58Fe, Iron fortified milk with ferric pyrophosphate labelled with 57FeOral 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 | 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 22956195Walczyk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Iron fortified milk with iron salt labelled with 58Fe and 57Fe in people with Healthy, run by Société des Produits Nestlé (SPN).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of iron absorption from FAP and from ferric pyrophosphate relative to Ferrous sulfate (time frame: 14 days post isotope consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05642689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.