Growth of Infants Fed an Elemental Medical Food

Healthy Infants Clinical Trial

Official title:

Growth of Infants Fed an Elemental Medical Food

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699386
• Other study ID #: AH73
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2012
• Last updated: October 2, 2012
• Start date: April 1999
• Est. completion date: December 2000

Study information

• Verified date: October 2012
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 2000
• Est. primary completion date: December 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 9 Days

Eligibility

Inclusion Criteria:

• Singleton, healthy infant

• Gestational age of 37 to 42 weeks

• Birth weight of 2500 grams or greater

• Age between birth and 9 days of age

• Parents agree to not administer mineral or vitamin supplements during the study period

• Parents agree to feed study formula exclusively for the duration of the study

Exclusion Criteria:

• Maternal, fetal or perinatal history which may have adverse effects on growth

• Multiple birth

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Other:
• Control Study Formula
feed as lib
• Experimental Study Formula
feed as lib

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa
United States	T&W Research	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	weight gain during the study period	14 days of age to 112 days of age	No
Secondary	Anthropometric Measurements	length, head circumference, and length gain	14 days of age to 112 days of age	No
Secondary	GI Tolerance	daily stool number, stool consistency, formula intake	At visits 14 and 28	No
Secondary	Lab Measurement	serum albumin	At 112 day visit	No