Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children
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ClinicalTrials.gov Identifier: NCT02203890 |
Recruitment Status :
Completed
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
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Tracking Information | ||||
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First Submitted Date | July 25, 2014 | |||
First Posted Date | July 30, 2014 | |||
Last Update Posted Date | July 30, 2014 | |||
Study Start Date | June 2012 | |||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children | |||
Official Title | Study on the Normative State and Inter- and Intra-individual Variation in Growth, Hematology, Hydration and Markers of Oxidation, Infection and Inflammation in Preschool Children With a Similar Dietary Intake | |||
Brief Summary | This study will provide the researchers with an opportunity for the investigation of the biomarkers and different human biology component variable interactions in children; information that can generate new correlations between markers not known at the moment. Regarding their analysis, variation could have multiple connotations. A categorical that refers to a specific state, established with a diagnostic standard. And a numerical, referring to a range or the absolute value limits in a continuous spectrum; this research will allow us to express variability in the distance amplitude of the obtained values level, as well as classifications or categories previously established in the possible cases. OBJECTIVES PRINCIPAL OBJECTIVE To estimate the inter and intra-individual variety in a selected series or biological variables determinant of growth, body composition, infection, oxidation, inflammation and hydration, in preschool children sharing the same institutional-based diet. SPECIFIC OBJECTIVES
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Detailed Description | Please note protocol is also available in Spanish. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Urine, feces, saliva and blood
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Sampling Method | Non-Probability Sample | |||
Study Population | Apparently healthy children who attend 3 daycare centers (one semi-urban, one urban-marginal and one rural) from the Secretariat of Beneficial Works of the First Lady (SOSEP) system in the Western Highlands in Quetzaltenango, Guatemala. | |||
Condition | Healthy | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Apparently Healthy
Apparently healthy preschool children who attend 3 daycare centers of the Secretariat of Beneficials Works of the First Lady in Guatemalan Western Highlands
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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 | Completed | |||
Actual Enrollment |
91 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | November 2012 | |||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 23 Months to 84 Months (Child) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Guatemala | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02203890 | |||
Other Study ID Numbers | CeSSIAM_02 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | María José Soto, Center for Studies of Sensory Impairment, Aging and Metabolism | |||
Study Sponsor | María José Soto | |||
Collaborators | Universidad de Granada | |||
Investigators |
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PRS Account | Center for Studies of Sensory Impairment, Aging and Metabolism | |||
Verification Date | July 2014 |