Healthy Term Infants Fed Milk-Based Formulas

• Sponsor: Abbott Nutrition (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01617889
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.

Condition or Disease	Intervention/Treatment	Phase
Healthy Term Infant	Other: Experimental powdered milk-based infant formula with an alternate fat blend; Other: A powdered milk-based infant formula, standard fat blend	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Powdered milk-based formula, standard fat blend	Other: A powdered milk-based infant formula, standard fat blend; formula to be consumed ad lib
Experimental: Powder milk-based formula, alternate fat blend	Other: Experimental powdered milk-based infant formula with an alternate fat blend; formula to be consumed ad lib

Outcome Measures

Primary Outcome Measures

1. calcium absorption [8 days]

   as measured in stool

Secondary Outcome Measures

1. stool consistency [28 days]

   measured on 5 point scale

2. fat absorption [8 days]

   as measured in stool

3. average number of stools per day [28 days]

4. percent of feedings with spit up/vomit associated with feeding per day. [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 53 Days to 115 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Infant is judged to be in good health.

• Infant is singleton from a full term birth

• Infant's birth weight was > 2490 g.

• Infant is between 53 and 115 days of age

• Infant is on infant formula and tolerating infant formula feedings

• Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.

• Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion Criteria:

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• Abbott Nutrition

Investigators

• Study Chair: John Lasekan, PhD, Abbott Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Nutrition
• ClinicalTrials.gov Identifier: NCT01617889
• Other Study ID Numbers: AK88
• First Posted: Jun 13, 2012
• Last Update Posted: Feb 15, 2013
• Last Verified: Feb 1, 2013

Study Results

No Results Posted as of Feb 15, 2013