Followup of Infants Fed Non-routine Infant Formula
This study has been completed.
Sponsor:
Mead Johnson Nutrition
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00665938
First received: March 28, 2008
Last updated: January 27, 2012
Last verified: January 2012
| Tracking Information | |||||
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| First Received Date ICMJE | March 28, 2008 | ||||
| Last Updated Date | January 27, 2012 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Achieved weight [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00665938 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Tolerance [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| 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 | Followup of Infants Fed Non-routine Infant Formula | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The purpose of this study is to compare physical development of infants fed one of three study formulas. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Other: Infant formula
Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL) Arm 2. partially hydrolyzed infant formula with probiotics Arm 3. extensively hydrolyzed infant formula with probiotics Other Name: No other names are applicable to the 3 intervention arms |
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| Study Arm (s) |
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| 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 | 183 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 4 Months to 4 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00665938 | ||||
| Other Study ID Numbers ICMJE | 3369-6, 3369-6 | ||||
| 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 2012 | ||||
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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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