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

Sponsor

María José Soto (Other)

Overall Status

Completed

CT.gov ID

NCT02203890

Collaborator

Universidad de Granada (Other)

Enrollment

Location

Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy

Detailed Description

Please note protocol is also available in Spanish.

Study Design

Study Type:

Observational

Actual Enrollment :

91 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Months to 84 Months

Sexes Eligible for Study:

All

Accepts 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.