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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02203890

Enrollment

Registered

2014-07-30

Start date

2012-06-30

Completion date

2012-11-30

Last updated

2014-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan children

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

23 Months to 84 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Weight	7th week of observation	Growth, measured trough weight (kg)
Hemoglobin	8th week of observation	Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
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.
Height	7th week of observation	Growth, measured trough height (cm).
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 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)
Urine Sodium	8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: sodium (mg/l)
Urine Potassium	8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: potassium (mg/l)
Urine Calcium	8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: calcium (mg/l)
Urine Magnesium	8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: magnesium (mg/l)
Urine Phosphorus	8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: inorganic phosphorus (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)
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).
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)
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)
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)
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)
Retinol	8th week of observation	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Retinol (mg/dl)
Alpha-tocopherol	8th week of observation	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Alpha-tocopherol (mg/l)
Beta-Carotenes	8th week of observation	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Beta-carotenes (mg/l)
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)
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)
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 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)
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)
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)
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)
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)
Fecal Calprotectin	8th week of observation	Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).
Intestinal Parasitosis	8th week of observation	Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.
Giardiasis Infection Presence-1	7th week of observation	Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
Giardiasis Infection Presence-2	8th week of observation	Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
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.
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.

Countries

Guatemala

Outcome results