Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends
Phase 4
Completed
- Conditions
- Infant
- Interventions
- Other: Infant formula milk based
- Registration Number
- NCT00941564
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
The objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain different fat blends.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures.
- Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids.
Exclusion Criteria
- Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics 3 days prior to enrollment.
- Infant has received probiotics-containing products 3 days prior to enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Commercially available infant formula A Infant formula milk based Varying fat blend from comparator product Commercially available infant formula B Infant formula milk based -
- Primary Outcome Measures
Name Time Method Calcium absorption 18 days
- Secondary Outcome Measures
Name Time Method Calcium retention, fat absorption, tolerance 18 days
Trial Locations
- Locations (1)
Department of Pediatrics, Federal University of Bahia
🇧🇷Salvador, Bahia, Brazil