The Evaluation of Cow Milk-Based Formulas
This study has been completed.
Sponsor:
Mead Johnson Nutrition
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00518414
First received: August 17, 2007
Last updated: January 4, 2008
Last verified: January 2008
| Tracking Information | |||||
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| First Received Date ICMJE | August 17, 2007 | ||||
| Last Updated Date | January 4, 2008 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Red Blood Cell (RBC) ARA and DHA | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00518414 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Phospholipid fatty acids, tolerance | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Evaluation of Cow Milk-Based Formulas | ||||
| Official Title ICMJE | The Evaluation of Cow Milk-Based Formulas - Study A | ||||
| Brief Summary | Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Term Infants | ||||
| Intervention ICMJE | Procedure: Blood draw | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | January 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 18 Days | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00518414 | ||||
| Other Study ID Numbers ICMJE | 3378 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kim Merkel, Mead Johnson | ||||
| Study Sponsor ICMJE | Mead Johnson Nutrition | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mead Johnson Nutrition | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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