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Search / Trial NCT04774016

Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Feb 25, 2021

Trial Information

Current as of August 11, 2025

Completed

Keywords

ClinConnect Summary

Iron stores of healthy, full-term neonates are supposed to cover iron needs for the first 4-6 months of life. After 6 months of age, requirements for absorbed iron are high, as infants need to build body iron stores and triple their body weight before the first year of life. Iron concentrations in mature breastmilk are low (\~0.3 mg/L) and cannot adequately cover the high iron requirements of children between 6 and 24 months of age. Follow-up formulas (FUF) are fortified milk-based products intended for infants above 6 months of age and young children aged 1-3 years, and are widely used as ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Written informed consent has been obtained from the parents/legally acceptable representative
  • Child aged 40-56 weeks (± 3 weeks)
  • Child exhibits no clinical signs/symptoms of chronic disease or acute illness
  • Capillary Hb ≥70 g/L
  • Anticipated residence in the area for the study duration
  • Z-scores for weight-for-age and weight-for-length both \>-3, if the infant is severely underweight or severely malnourished.
  • Singleton, full-term gestation birth (≥37 weeks)
  • Birth weight ≥2.5 kg and ≤4.5 kg
  • Exclusion Criteria:
  • Child exhibits clinical signs/symptoms of chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth
  • Child received vitamin and mineral supplements in the 2 weeks prior to enrollment
  • Child is exclusively breastfed
  • Child received antibiotic treatments in the 4 weeks prior to enrollment
  • Parents or caretakers not willing/not able to comply with the requirements of the study protocol
  • Child has allergy or intolerance to cows' milk protein or lactose, or severe food allergies
  • Child is participating in any other interventional clinical trial that would interfere with study outcomes

About Société Des Produits Nestlé (Spn)

Société des Produits Nestlé (SPN) is a global leader in nutrition, health, and wellness, dedicated to advancing scientific research and innovation in the food and beverage sector. As a subsidiary of Nestlé S.A., SPN focuses on developing high-quality products that promote healthier lifestyles and improve overall well-being. The organization actively sponsors clinical trials to evaluate the efficacy and safety of its nutritional offerings, collaborating with healthcare professionals and research institutions to gather valuable insights that inform product development and public health initiatives. Through its commitment to evidence-based research, SPN aims to enhance consumer trust and contribute to the advancement of nutritional science.

Locations

Samut Sakhon, , Thailand

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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