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

NCT ID: NCT00941564

Last Updated: 2010-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Commercially available infant formula A

Varying fat blend from comparator product

Group Type EXPERIMENTAL

Infant Formula milk based

Intervention Type OTHER

Consume ad lib

Commercially available infant formula B

Group Type ACTIVE_COMPARATOR

Infant formula milk based

Intervention Type OTHER

consume ad lib

Interventions

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Infant Formula milk based

Consume ad lib

Intervention Type OTHER

Infant formula milk based

consume ad lib

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

84 Days

Maximum Eligible Age

159 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Nutrition

Principal Investigators

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John Lasekan, PhD

Role: STUDY_DIRECTOR

Abbott Nutrition

Locations

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Department of Pediatrics, Federal University of Bahia

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

References

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Souza CO, Leite MEQ, Lasekan J, Baggs G, Pinho LS, Druzian JI, Ribeiro TCM, Mattos AP, Menezes-Filho JA, Costa-Ribeiro H. Milk protein-based formulas containing different oils affect fatty acids balance in term infants: A randomized blinded crossover clinical trial. Lipids Health Dis. 2017 Apr 14;16(1):78. doi: 10.1186/s12944-017-0457-y.

Reference Type DERIVED
PMID: 28410612 (View on PubMed)

Leite ME, Lasekan J, Baggs G, Ribeiro T, Menezes-Filho J, Pontes M, Druzian J, Barreto DL, de Souza CO, Mattos A, Costa-Ribeiro H Jr. Calcium and fat metabolic balance, and gastrointestinal tolerance in term infants fed milk-based formulas with and without palm olein and palm kernel oils: a randomized blinded crossover study. BMC Pediatr. 2013 Dec 24;13:215. doi: 10.1186/1471-2431-13-215.

Reference Type DERIVED
PMID: 24367946 (View on PubMed)

Other Identifiers

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AK76

Identifier Type: -

Identifier Source: org_study_id