Iron StatusNCT07324135
Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
A study testing Nutritional product in people with Iron Status, run by Nutricia Research at 1 site in Indonesia.
Trial summary
This study evaluates the effect of young child formula in children 1-3 years of age. Subjects will receive either test or control product. Growth and health data, parent diaries and biological samples will be collected during the study. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron Status
- What is being tested?
- Nutritional product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Mar 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 1 to 3 years
- Healthy children (as per investigator clinical judgement and non-anaemic as confirmed by Hb levels) or meeting the criteria for mild anaemia based on Hb levels
- Children familiar with drinking milk products (in combination with breastfeeding or not) for at least 3 weeks prior to screening.
- Written informed consent provided by parent(s) / legally acceptable representative(s) aged ≥18 years at screening
Who cannot join
- Low Hb meeting the criteria for moderate or severe anaemia
- Use of iron and/or fibre supplementation within 3 months prior to screening
- Any infection within 2 weeks prior to screening
- Any other medical condition with known high CRP (>5 mg/L) / high AGP (>1 g/L) value within 2 weeks prior to screening
- The use of medication that is likely to interfere with iron metabolism) within 2 weeks prior to screening
- The use of medication to treat iron deficiency or anaemia within 3 months prior to screening
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- Any developmental delays that could impact feeding behaviour or growth, or any other condition that is likely to influence nutritional status or growth.
- Disorders requiring a special diet.
- Any other iron metabolism and related disorders
- Children with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Danone Global Research & Innovation Center (Nutricia Research) contact
Indonesia1 site, 1 recruiting
- Recruiting
Faculty of Medicine University of Indonesia
Jakarta
Principal Investigator
About this study
Official title: A Double-blind Randomized Controlled Study to Evaluate the Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
This study evaluates the effect of young child formula in children 1-3 years of age. Subjects will receive either test or control product. Growth and health data, parent diaries and biological samples will be collected during the study.
- Conditions
- Iron Status
- Being tested
- Nutritional product
- Keywords
- YCF, Young Child Formula, Anaemia, Iron status
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional productOther
parents will be instructed to provide subjects with 2-3 servings of Study Product per day
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Young Child Formula Receives: Other: Nutritional product |
| Control product | Other | Control: cow's milk Receives: Other: Nutritional product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin concentration
Measured: Baseline and 20 weeks post baseline
Secondary outcomes (1)
Daily iron intake
Measured: Baseline, 10 weeks and 20 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start13 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron StatusStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind, parallel-group, multi-centre intervention study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324135
- Sponsor's protocol ID
- 24REX0077885
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Study to Evaluate the Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
- ClinicalTrials.gov ID
- NCT07324135
- Acronym / sponsor ID
- 24REX0077885
- Conditions
- Iron Status
- Keywords
- YCF, Young Child Formula, Anaemia, Iron status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Jan 2026 (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.
This study evaluates the effect of young child formula in children 1-3 years of age. Subjects will receive either test or control product. Growth and health data, parent diaries and biological samples will be collected during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blind, parallel-group, multi-centre intervention study
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Other: Nutritional productYoung Child Formula |
| Control product | Other | Other: Nutritional productControl: cow's milk |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 1 to 3 years
- Healthy children (as per investigator clinical judgement and non-anaemic as confirmed by Hb levels) or meeting the criteria for mild anaemia based on Hb levels
- Children familiar with drinking milk products (in combination with breastfeeding or not) for at least 3 weeks prior to screening.
- Written informed consent provided by parent(s) / legally acceptable representative(s) aged ≥18 years at screening
Key exclusion criteria (10 listed)
- Low Hb meeting the criteria for moderate or severe anaemia
- Use of iron and/or fibre supplementation within 3 months prior to screening
- Any infection within 2 weeks prior to screening
- Any other medical condition with known high CRP (>5 mg/L) / high AGP (>1 g/L) value within 2 weeks prior to screening
- The use of medication that is likely to interfere with iron metabolism) within 2 weeks prior to screening
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 |
|---|---|---|
| Nutritional productparents will be instructed to provide subjects with 2-3 servings of Study Product per day | Other | Control product, Test product |
Primary outcome
Serum ferritin concentration
Time frame: Baseline and 20 weeks post baseline
1 secondary outcome
Daily iron intake
Time frame: Baseline, 10 weeks and 20 weeks post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- 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.
Danone Global Research & Innovation Center (Nutricia Research) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional product in people with Iron Status, run by Nutricia Research at 1 site in Indonesia.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danone Global Research & Innovation Center (Nutricia Research) (+31 30 2095 000, register.clinicalresearchnutricia@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum ferritin concentration (time frame: Baseline and 20 weeks post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.