ClinicalTrials.gg
RecruitingNCT07324135Updated Sep 1, 2026

Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.

An interventional study of Nutritional product in Iron Status, sponsored by Nutricia Research. Recruiting at 1 site in Indonesia. Open to participants aged 12 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Nutricia Research (part of Danone) · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
466
Allocation
Randomized
Ages
12 Months to 36 Months
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Anemia with a site in Indonesia — 4 open to participants now, 5 under way, 1 of them phase 3. Anemia · Indonesia.

Planned enrollment
4th of 15
466 · median 324
Started
2026
with 2 others
No phase
7 of 17
1 open now
Registered
15th of 17
by date

Among the 17 studies in Anemia with a site in Indonesia, this one is the 4th largest by planned enrollment of the 15 interventional ones, is one of 3 that started in 2026, is one of 7 with no phase, and was the 15th registered.

By phase

17 studies; the count open now beside each. This study's row is marked.

No phasethis study7 · 1 open
Phase 35 · 1 open
Observational2 · 2 open
Phase 11 · 0 open
Phase 21 · 0 open
Phase 41 · 0 open

By the year they started

First in 2006; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 324 across the 15 interventional studies, 145 across the 2 observational. Of the 6 that completed or were terminated, 2 (33%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 17 studies in Anemia with a site in Indonesia, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Iron Status

Browse trials for

Keywords

  • YCF
  • Young Child Formula
  • Anaemia
  • Iron status
04

Who can participate

Ages eligible
12 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children aged 1 to 3 years
  • Healthy children (as per investigator clinical judgement and non-anaemic as confirmed by 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 provided by parent(s) / legally acceptable representative(s) aged ≥18 years at screening

Exclusion criteria

Exclusion Criteria:

  • Low 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
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
466 participants (estimated)

Study arms

  • Experimental
    Test product

    Young Child Formula

    Other: Nutritional product

  • Other
    Control product

    Control: cow's milk

    Other: Nutritional product

Interventions

  • OtherNutritional product

    parents will be instructed to provide subjects with 2-3 servings of Study Product per day

06

What researchers measure

Primary outcomes

  1. Serum ferritin concentration

    Time frame: Baseline and 20 weeks post baseline

Secondary outcomes

  1. Daily iron intake

    Time frame: Baseline, 10 weeks and 20 weeks post-baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.

Of 177 interventional studies with no phase under Anemia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 23, 2025
First posted
Jan 7, 2026
StartActual
Mar 13, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Jan 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07324135
Lead sponsor
Nutricia Research
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Mar 13, 2026
Primary completion
Dec 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Danone Global Research & Innovation Center (Nutricia Research)
Contact
register.clinicalresearchnutricia@danone.com
+31 30 2095 000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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