Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children

Tracking Information
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; (submitted: August 10, 2010)	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)
Original Primary Outcome Measures ICMJE; (submitted: August 9, 2010)	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)
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
Condition ICMJE	Cardiovascular Diseases
Intervention ICMJE	Other: Modification of the content of fat in milk Comparison of three levels of fat content in cow´s milk Other Name: Liconsa milk; Other: Modification of the content of cows milk Comparison of three levels of fat content in cows' milk Other Name: Liconsa low fat milk; Other: Modification of the fat content of cows´ milk Comparison of three levels of fat content in cow´milk Other Name: Liconsa defatted milk
Study Arms	Sham Comparator: Full fat milk Full fat milk contain 3% fat Intervention: Other: Modification of the content of fat in milk; Experimental: Partially defatted milk Partially defatted milk contains 2% of fat Intervention: Other: Modification of the content of cows milk; Experimental: Defatted milk Defatted milk contains 1% fat Intervention: Other: Modification of the fat content of cows´ milk
Publications *	Stevens G, Dias RH, Thomas KJ, Rivera JA, Carvalho N, Barquera S, Hill K, Ezzati M. Characterizing the epidemiological transition in Mexico: national and subnational burden of diseases, injuries, and risk factors. PLoS Med. 2008 Jun 17;5(6):e125. doi: 10.1371/journal.pmed.0050125.; Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6.; Freedman DS. Clustering of coronary heart disease risk factors among obese children. J Pediatr Endocrinol Metab. 2002 Sep-Oct;15(8):1099-108.; Aguilar-Salinas CA, Gómez Pérez FJ, Rull Rodrigo J, Villalpando S, Barquera S, Rojas R. Prevalence of dyslipidemias in the 2006 Encuesta Nacional de Salud y Nutrición. Salud Pub Mex, 2010; 52 Sppl 1: S44-S53.; Corvalán C, Uauy R, Kain J, Martorell R. Obesity indicators and cardiometabolic status in 4-y-old children. Am J Clin Nutr. 2010 Jan;91(1):166-74. doi: 10.3945/ajcn.2009.27547. Epub 2009 Nov 18.; Villalpando S, Carrión C, Barquera S, Olaiz G, Robledo R. The body mass index is associated with hyperglycemia and alterations of some components of the metabolic syndrome in Mexican adolescents aged 10-19 years. Salud Pub Mex 2007; 49:s324-s330.; Webber LS, Srinivasan SR, Wattigney WA, Berenson GS. Tracking of serum lipids and lipoproteins from childhood to adulthood. The Bogalusa Heart Study. Am J Epidemiol. 1991 May 1;133(9):884-99.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 24, 2011)	650
Original Estimated Enrollment ICMJE; (submitted: August 9, 2010)	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: Attending selected boarding schools Exclusion Criteria: No lactose intolerance
Sex/Gender	Sexes Eligible for Study: All
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 )
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	Principal Investigator: Salvador Villalpando, MD, Ph D Instituto Nacional de Salud Publica, Mexico Study Chair: Teresa Shamah, M. Sc. Instituto Nacional de Salud Publica, Mexico Study Chair: Yaveth Lara, M Sc Instituto Nacional de Salud Publica, Mexico
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