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

Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941564
• Other study ID #: AK76
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2009
• Last updated: November 24, 2010
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: November 2010
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 84 Days to 159 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant

Intervention

Other:
• Infant Formula milk based
Consume ad lib
• Infant formula milk based
consume ad lib

Locations

Country	Name	City	State
Brazil	Department of Pediatrics, Federal University of Bahia	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium absorption		18 days	No
Secondary	Calcium retention, fat absorption, tolerance		18 days	No