Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children

Study Overview
=================
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 To determine the inter and intra-individual variation of growth in preschool children, with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system daycare centers and to compare between semi-urban and rural. To describe the inter-individual variation of the red blood cells circulating mass in preschool children, with a similar diet, who attend day care centers and to compare between semi-urban and rural. To determine the inter-individual variation of systemic and intraintestinal oxidation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural. To describe the inter-individual variation of systemic and intraintestinal inflammation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural. To determine the inter and/or intra-individual variation of urinary tract infection and gastrointestinal parasite infestation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural. To describe the inter and intra-individual variation of the hydration status in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural. To explore intra-individual associations in variables of the same research component or different component variables.

Detailed Description
-----------------
Please note protocol is also available in Spanish.

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

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be attending one of the SOSEP systems assigned daycare centers To maintain an attendance of 80% during the 8 weeks of the fieldwork Aged 23 to 84 months Being apparently healthy and with no dietary restrictions related to the foods offered with the SOSEP menu. Exclusion Criteria: Children whose parents of caregivers did not sign a consent form Children who refused to participate in the study Children who refused to adhere to the collections routines.

Ages Eligible for Study
-----------------
Minimum Age: 23 Months
Maximum Age: 84 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apparently Healthy<br>Apparently healthy preschool children who attend 3 daycare centers of the Secretariat of Beneficials Works of the First Lady in Guatemalan Western Highlands | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Growth, measured trough weight (kg) | 7th week of observation | 
| Hemoglobin | Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala. | 8th week of observation | 
| Urine Osmolality-1 | Hydration Status= measured in 24-h urine through urine volume and osmolality in osmometer Model Löser 815. Results in mOsm/kg. | 6th week of observation | 
| Height | Growth, measured trough height (cm). | 7th week of observation | 
| Urine Osmolality-2 | Hydration Status= measured in 24-h urine through urine volume and osmolality Osmometer Model Löser 815. Results in mOsm/kg. | 7th week of observation | 
| Urine Osmolality-3 | Hydration Status= measured in 24-h urine through urine volume and osmolality in two different osmometers (Löser 815 and Osmomat 030). Results in mOsm/kg. | 8th week of observation | 
| Urine Urea | Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: urea (mg/l) | 8th week of oservation | 
| Urine Uric Acid | Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: uric acid (mg/l) | 8th week of oservation | 
| Urine Sodium | Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: sodium (mg/l) | 8th week of oservation | 
| Urine Potassium | Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: potassium (mg/l) | 8th week of oservation | 
| Urine Calcium | Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: calcium (mg/l) | 8th week of oservation | 
| Urine Magnesium | Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: magnesium (mg/l) | 8th week of oservation | 
| Urine Phosphorus | Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: inorganic phosphorus (mg/l) | 8th week of oservation | 
| Urine 15-f2t-Isoprostanes | Urine Oxidation biomarkers: 15-f2t-Isoprostanes (ng/mL) Measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada using ELISA assay kit (Oxford Biomedical Research, Inc., Catalog # EA84.102606, Michigan, USA) | 8th week of observation | 
| Urine 8-Hydroxydeoxyguanosine | Urine Oxidation biomarkers: 8-Hydroxydeoxyguanosine (ng/mL) Measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada using ELISA assay kits (JaICA, Nikken SEIL Co., Ltd, Catalog# IM-KOGHS 040914E, Shizouka, Japan). | 8th week of observation | 
| Catalase Activity | Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system: Catalase Activity (nmol/seg/g Hb) | 8th week of observation | 
| Superoxide Dismutase Activity | Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Superoxide Dismutase Activity (U/g Hb) | 8th week of observation | 
| Gluthathione Reductase | Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Gluthathione Reductase Activity (umol/min/g Hb) | 8th week of observation | 
| Gluthathione Peroxidase | Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Gluthathione Peroxidase Activity (uU/g Hb) | 8th week of observation | 
| Retinol | Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Retinol (mg/dl) | 8th week of observation | 
| Alpha-tocopherol | Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Alpha-tocopherol (mg/l) | 8th week of observation | 
| Beta-Carotenes | Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Beta-carotenes (mg/l) | 8th week of observation | 
| Coenzyme Q9 | Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q9 (mg/l) | 8th week of observation | 
| Coenzyme Q10 | Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q10 (mg/l) | 8th week of observation | 
| Plasma Interleukin-1B | Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma IL-1B (pg/ml) | 8th week of observation | 
| Plasma Interleukin-6 | Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma IL-6 (pg/ml) | 8th week of observation | 
| Plasma Interleukin-8 | Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma IL-8 (pg/ml) | 8th week of observation | 
| Plasma Interleukin-10 | Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma IL-10 (pg/ml) | 8th week of observation | 
| Plasma Tumor Necrosis Factor-Alpha | Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma Tumor Necrosis Factor-Alpha (pg/ml) | 8th week of observation | 
| Saliva Interleukin-1B | Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-1B (pg/ml) | 8th week of observation | 
| Saliva Interleukin-6 | Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-6 (pg/ml) | 8th week of observation | 
| Saliva Interleukin-8 | Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-8 (pg/ml) | 8th week of observation | 
| Saliva Interleukin-10 | Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system Saliva IL-10 (pg/ml) | 8th week of observation | 
| Saliva Tumor Necrosis Factor-Alpha | Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva Tumor Necrosis Factor-Alpha (pg/ml) | 8th week of observation | 
| Fecal Calprotectin | Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100). | 8th week of observation | 
| Intestinal Parasitosis | Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces. | 8th week of observation | 
| Giardiasis Infection Presence-1 | Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D) | 7th week of observation | 
| Giardiasis Infection Presence-2 | Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D) | 8th week of observation | 
| White Urine Cell Count | White urine cell count (per field), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala. | 8th week of observation | 
| White Blood Cell Count | White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala. | 8th week of observation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan children