Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children
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ClinicalTrials.gov Identifier: NCT01178515 |
Recruitment Status
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Completed
First Posted
: August 10, 2010
Last Update Posted
: June 27, 2011
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Sponsor:
Instituto Nacional de Salud Publica, Mexico
Information provided by:
Instituto Nacional de Salud Publica, Mexico
Tracking Information | ||||||||||
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First Submitted Date ICMJE | August 9, 2010 | |||||||||
First Posted Date ICMJE | August 10, 2010 | |||||||||
Last Update Posted Date | June 27, 2011 | |||||||||
Study Start Date ICMJE | September 2010 | |||||||||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Cardiovascular risk indicators [ Time Frame: 4 months ] Cardiovascular risk is indicated by several determinations of blood fats namely: Total cholesterol, triglicerides, Low-density lipoprotein (LDL) and High density lipoprotein (HDL) cholesterol, lipoproteins: Apo a1,Apo B100 and Lp(a)
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Original Primary Outcome Measures ICMJE |
Cardiovascular risk indicators [ Time Frame: 4 months ] Cardiovascular risk is indicated by several determinations of blood fats namely: Total cholesterol triglicerides, LDL y HDL cholesterol, lipoproteins Apo a1,Apo B100 and Lp(a)
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Change History | Complete list of historical versions of study NCT01178515 on ClinicalTrials.gov Archive Site | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Current Other Outcome Measures ICMJE | Not Provided | |||||||||
Original Other Outcome Measures ICMJE | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children | |||||||||
Official Title ICMJE | Impact of Low Fat Milk Intake on Cardiovascular Risk Indicators in Children 6-13 Years of Age | |||||||||
Brief Summary | Substituting whole milk intake for defatted milk will improve indicators of cardiovascular risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican children 6-13 years of age. | |||||||||
Detailed Description | Double blind trial in 600 children 6-13 years of age residing in 12 boarding schools. Schools will be randomized to distribute three types of milk namely: full fat milk (3% fat), partially defatted milk (2% fat) or defatted milk (1% fat) for 90 days of effective exposure (4 months total duration). Subjects will receive 400 mL of the corresponding milk every day (200 mL breakfast and 200 mL night meal) from Monday through Friday. During week ends they will eat a freely chosen diet at home. Milk intake will be measured every day. Diet by 24 h-recall. will be evaluated every month. Blood samples will be obtained at the beginning and at the end of the intervention. | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase | Phase 4 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Cardiovascular Diseases | |||||||||
Intervention ICMJE |
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Study Arms |
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Publications * |
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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 | |||||||||
Actual Enrollment ICMJE |
650 | |||||||||
Original Estimated Enrollment ICMJE |
600 | |||||||||
Actual Study Completion Date | May 2011 | |||||||||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 6 Years to 13 Years (Child) | |||||||||
Accepts Healthy Volunteers | Yes | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Mexico | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT01178515 | |||||||||
Other Study ID Numbers ICMJE | Milk, Cardiovas risk, children 1-865-6540 ( Other Identifier: Ethics Committee, Instituto Nacional Salud Pub, Mexico ) |
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Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement | Not Provided | |||||||||
Responsible Party | Dr. Salvador Villalpando, Instituto Nacional de Salud Publica | |||||||||
Study Sponsor ICMJE | Instituto Nacional de Salud Publica, Mexico | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
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PRS Account | Instituto Nacional de Salud Publica, Mexico | |||||||||
Verification Date | June 2011 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |