Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children
- Conditions
- Healthy
- Registration Number
- NCT02203890
- Lead Sponsor
- María José Soto
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Urine Osmolality-3 8th week of observation 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.
Urine Urea 8th week of oservation Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
urea (mg/l)Urine Uric Acid 8th week of oservation Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
uric acid (mg/l)Weight 7th week of observation Growth, measured trough weight (kg)
Urine Osmolality-1 6th week of observation Hydration Status= measured in 24-h urine through urine volume and osmolality in osmometer Model Löser 815. Results in mOsm/kg.
Urine Osmolality-2 7th week of observation Hydration Status= measured in 24-h urine through urine volume and osmolality Osmometer Model Löser 815. Results in mOsm/kg.
Urine Phosphorus 8th week of oservation Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
inorganic phosphorus (mg/l)Urine 8-Hydroxydeoxyguanosine 8th week of observation 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).Retinol 8th week of observation Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Retinol (mg/dl)Hemoglobin 8th week of observation Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
Height 7th week of observation Growth, measured trough height (cm).
Urine Calcium 8th week of oservation Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
calcium (mg/l)Superoxide Dismutase Activity 8th week of observation 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)
Plasma Interleukin-1B 8th week of observation 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)Saliva Interleukin-6 8th week of observation 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)
Giardiasis Infection Presence-2 8th week of observation Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
Urine Potassium 8th week of oservation Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
potassium (mg/l)Urine Magnesium 8th week of oservation Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
magnesium (mg/l)Catalase Activity 8th week of observation 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)Plasma Interleukin-8 8th week of observation 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)Plasma Interleukin-10 8th week of observation 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)Saliva Interleukin-10 8th week of observation 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)
Saliva Tumor Necrosis Factor-Alpha 8th week of observation 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)White Urine Cell Count 8th week of observation White urine cell count (per field), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
Urine Sodium 8th week of oservation Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
sodium (mg/l)Urine 15-f2t-Isoprostanes 8th week of observation 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)Gluthathione Reductase 8th week of observation 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)
Alpha-tocopherol 8th week of observation Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Alpha-tocopherol (mg/l)Saliva Interleukin-8 8th week of observation 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)
Intestinal Parasitosis 8th week of observation Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.
Gluthathione Peroxidase 8th week of observation 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)
Beta-Carotenes 8th week of observation Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Beta-carotenes (mg/l)Plasma Interleukin-6 8th week of observation 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)Plasma Tumor Necrosis Factor-Alpha 8th week of observation 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)Saliva Interleukin-1B 8th week of observation 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)
Giardiasis Infection Presence-1 7th week of observation Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
Coenzyme Q9 8th week of observation Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Coenzyme Q9 (mg/l)Coenzyme Q10 8th week of observation Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Coenzyme Q10 (mg/l)Fecal Calprotectin 8th week of observation Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).
White Blood Cell Count 8th week of observation White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center for Studies of Sensory Impairment Aging and Metabolism
🇬🇹Guatemala, Quetzaltenango, Guatemala