Healthy Term Infants Fed Milk-Based Formulas
This study has been completed.
Sponsor:
Abbott Nutrition
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01617889
First received: June 10, 2012
Last updated: February 14, 2013
Last verified: February 2013
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Purpose
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 | Intervention | 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 Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends |
Resource links provided by NLM:
Further study details as provided by Abbott Nutrition:
Primary Outcome Measures:
- calcium absorption [ Time Frame: 8 days ] [ Designated as safety issue: No ]as measured in stool
Secondary Outcome Measures:
- stool consistency [ Time Frame: 28 days ] [ Designated as safety issue: No ]measured on 5 point scale
- fat absorption [ Time Frame: 8 days ] [ Designated as safety issue: No ]as measured in stool
- average number of stools per day [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- percent of feedings with spit up/vomit associated with feeding per day. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | March 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 53 Days to 115 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 More Information
No publications provided
| Responsible Party: | Abbott Nutrition |
| ClinicalTrials.gov Identifier: | NCT01617889 History of Changes |
| Other Study ID Numbers: | AK88 |
| Study First Received: | June 10, 2012 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 23, 2013