Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends
"Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends"
1 other identifier
interventional
33
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 17, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedNovember 25, 2010
November 1, 2010
2 months
July 14, 2009
November 24, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Calcium absorption
18 days
Secondary Outcomes (1)
Calcium retention, fat absorption, tolerance
18 days
Study Arms (2)
Commercially available infant formula A
EXPERIMENTALVarying fat blend from comparator product
Commercially available infant formula B
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
Department of Pediatrics, Federal University of Bahia
Salvador, Estado de Bahia, Brazil
Related Publications (2)
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.
PMID: 28410612DERIVEDLeite 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.
PMID: 24367946DERIVED
Study Officials
- STUDY DIRECTOR
John Lasekan, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 17, 2009
Study Start
March 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
November 25, 2010
Record last verified: 2010-11