Status:
COMPLETED
Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Iron Absorption
Eligibility:
All Genders
40-56 years
Phase:
NA
Brief Summary
The co-primary objectives of this study are: 1) to investigate the effect adding a synbiotic (combination of a pre-and probiotic) to iron-fortified follow-up formula (FUF) on iron bioavailability, and...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04774016
Start Date
November 18 2020
End Date
June 7 2021
Last Update
March 24 2023
Active Locations (1)
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1
Amphawa Hospital
Samut Sakhon, Thailand