A Double-blind Randomized Controlled Study to Evaluate the Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
| Registry | NCT07324135 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, basic science |
| Enrollment | 466 (Estimated) |
| Sponsor | Nutricia Research (Industry) |
| Conditions | Iron Status |
| Interventions | Nutritional product (Other) |
| Dates | start 2026-03-13, primary completion 2026-12-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-01-07, last updated 2026-09-01 |
| Locations | 1 site in Indonesia |
Related Papers Related Patents Related Grants Related Experts
All trials for Iron Status All trials of Nutritional product
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test product | Experimental | Other: Nutritional product | Young Child Formula |
| Control product | Other | Other: Nutritional product | Control: cow's milk |
Sex: All, ages: 12 Months to 36 Months, accepts healthy volunteers
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Faculty of Medicine University of Indonesia | Jakarta | Indonesia | Recruiting |