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

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.

Study Overview

• Status: Completed
• Conditions: Healthy

Detailed Description

Please note protocol is also available in Spanish.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Guatemala
  • Quetzaltenango
    • Guatemala, Quetzaltenango, Guatemala, 09001
      • Center for Studies of Sensory Impairment Aging and Metabolism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

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

Collaborators and Investigators

• Sponsor: María José Soto
• Collaborators: Universidad de Granada
• Investigators: Principal Investigator: Maria J. Soto-Méndez, MSc, Center for Studies of Sensory Impairment, Aging and Metabolism

Publications and helpful links

General Publications

• Soto-Méndez M, Campos-Oliva R, Aguilera C, Solomons N, Schümann K, Gil A. Urinary osmolality of preschool children with a largely common weekday meal offering, from the western highlands of Guatemala. Spanish J Community Nutr. 20:13-9, 2014.
• Soto-Mendez MJ, Romero-Abal ME, Schumann K, Gil A, Solomons NW. Normative Fecal Calprotectin Concentrations in Guatemalan Preschoolers Are High Relative to Children Reported Elsewhere. J Pediatr Gastroenterol Nutr. 2017 Feb;64(2):238-244. doi: 10.1097/MPG.0000000000001241.
• Soto-Mendez MJ, Aguilera CM, Campana-Martin L, Martin-Laguna V, Schumann K, Solomons NW, Gil A. Variation in hydration status within the normative range is associated with urinary biomarkers of systemic oxidative stress in Guatemalan preschool children. Am J Clin Nutr. 2015 Oct;102(4):865-72. doi: 10.3945/ajcn.114.105429. Epub 2015 Aug 12.
• Soto-Mendez MJ, Aguilera CM, Mesa MD, Campana-Martin L, Martin-Laguna V, Solomons NW, Schumann K, Gil A. Interaction of Giardia intestinalis and Systemic Oxidation in Preschool Children in the Western Highlands of Guatemala. J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):118-22. doi: 10.1097/MPG.0000000000000891.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 25, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 28, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Inflammation; Infection; Hydration; Growth; Hematology; Oxidation; Guatemalan children
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Infections
• Other Study ID Numbers: CeSSIAM_02