NCT00941564CompletedPhase 4
"Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends"
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Calcium absorption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 84 Days to 159 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Calcium absorption
Time Frame: 18 days
Secondary Outcomes
- Calcium retention, fat absorption, tolerance(18 days)
Investigators
Study Sites (1)
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