Tolerance and Development of Healthy, Term Infants

Abbott

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Other: Alternate protein infant formula; Other: Standard infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT00465764

AK44

Details and patient eligibility

About

To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.

Enrollment: 115 patients

Sex: All

Ages: 1 to 8 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy term infants;
• Age 0-8 days of age;
• Exclusively formula fed;
• No use of vitamin/mineral supplements.

Exclusion criteria

• Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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115 participants in 2 patient groups

Protein formula

Experimental group

Description:

Feed as per HCP direction

Treatment:

Other: Alternate protein infant formula

Standard infant formula

Active Comparator group

Description:

Feed as per HCP instructions

Treatment:

Other: Standard infant formula