Infants Clinical Trial
Official title:
Healthy Term Infants Fed Milk-Based Formulas With A Supplemental Carotenoid
Verified date | March 2015 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.
Status | Terminated |
Enrollment | 91 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 28 Days |
Eligibility |
Inclusion Criteria: - Infant is in good health - Infant is a singleton from a full term birth with a gestational age of 37-42 weeks - Infant's birth weight was > 2490 g (~5 lbs 8 oz) - Infant is between 14 and 28 days of age - Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study - Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study Exclusion Criteria: - An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development. - Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | Dayton Clinical Research | Dayton | Ohio |
United States | Northpoint Pediatrics | Indianapolis | Indiana |
United States | Midwest Children's Health Research Institute | Lincoln | Nebraska |
United States | Institute of Clinical Research | Mayfield Heights | Ohio |
United States | Tuscon Medical Center | Tuscon | Arizona |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Carotenoid Concentration | Plasma sample | Change from Baseline to end of Study Period A (~21 Days) | No |
Secondary | Carotenoid Concentration | Plasma sample | Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days) | No |
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