Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends

Abbott

Status and phase: Completed; Phase 4

Conditions: Infant

Treatments: Other: Infant formula milk based; Other: Infant Formula milk based

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941564

AK76

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 84 to 159 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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33 participants in 2 patient groups

Commercially available infant formula A

Experimental group

Description:

Varying fat blend from comparator product

Treatment:

Other: Infant Formula milk based

Commercially available infant formula B

Active Comparator group

Treatment:

Other: Infant formula milk based