Infant
Conditions
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.
Interventions
OTHERInfant Formula milk based
Consume ad lib
OTHERInfant formula milk based
consume ad lib
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
84 Days to 159 Days
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calcium absorption | 18 days |
Secondary
| Measure | Time frame |
|---|---|
| Calcium retention, fat absorption, tolerance | 18 days |
Countries
Brazil
Outcome results
None listed