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

28 juillet 2014 mis à jour par: María José Soto

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.

Aperçu de l'étude

Statut

Complété

Les conditions

En bonne santé

Description détaillée

Please note protocol is also available in Spanish.

Type d'étude

Observationnel

Inscription (Réel)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 an à 7 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Weight Délai: 7th week of observation	Growth, measured trough weight (kg)	7th week of observation
Hemoglobin Délai: 8th week of observation	Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.	8th week of observation
Urine Osmolality-1 Délai: 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.	6th week of observation
Height Délai: 7th week of observation	Growth, measured trough height (cm).	7th week of observation
Urine Osmolality-2 Délai: 7th week of observation	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 Délai: 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.	8th week of observation
Urine Urea Délai: 8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: urea (mg/l)	8th week of oservation
Urine Uric Acid Délai: 8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: uric acid (mg/l)	8th week of oservation
Urine Sodium Délai: 8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: sodium (mg/l)	8th week of oservation
Urine Potassium Délai: 8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: potassium (mg/l)	8th week of oservation
Urine Calcium Délai: 8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: calcium (mg/l)	8th week of oservation
Urine Magnesium Délai: 8th week of oservation	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: magnesium (mg/l)	8th week of oservation
Urine Phosphorus Délai: 8th week of oservation	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 Délai: 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)	8th week of observation
Urine 8-Hydroxydeoxyguanosine Délai: 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).	8th week of observation
Catalase Activity Délai: 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)	8th week of observation
Superoxide Dismutase Activity Délai: 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)	8th week of observation
Gluthathione Reductase Délai: 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)	8th week of observation
Gluthathione Peroxidase Délai: 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)	8th week of observation
Retinol Délai: 8th week of observation	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Retinol (mg/dl)	8th week of observation
Alpha-tocopherol Délai: 8th week of observation	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Alpha-tocopherol (mg/l)	8th week of observation
Beta-Carotenes Délai: 8th week of observation	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Beta-carotenes (mg/l)	8th week of observation
Coenzyme Q9 Délai: 8th week of observation	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q9 (mg/l)	8th week of observation
Coenzyme Q10 Délai: 8th week of observation	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q10 (mg/l)	8th week of observation
Plasma Interleukin-1B Délai: 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)	8th week of observation
Plasma Interleukin-6 Délai: 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)	8th week of observation
Plasma Interleukin-8 Délai: 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)	8th week of observation
Plasma Interleukin-10 Délai: 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)	8th week of observation
Plasma Tumor Necrosis Factor-Alpha Délai: 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)	8th week of observation
Saliva Interleukin-1B Délai: 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)	8th week of observation
Saliva Interleukin-6 Délai: 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)	8th week of observation
Saliva Interleukin-8 Délai: 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)	8th week of observation
Saliva Interleukin-10 Délai: 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)	8th week of observation
Saliva Tumor Necrosis Factor-Alpha Délai: 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)	8th week of observation
Fecal Calprotectin Délai: 8th week of observation	Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).	8th week of observation
Intestinal Parasitosis Délai: 8th week of observation	Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.	8th week of observation
Giardiasis Infection Presence-1 Délai: 7th week of observation	Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)	7th week of observation
Giardiasis Infection Presence-2 Délai: 8th week of observation	Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)	8th week of observation
White Urine Cell Count Délai: 8th week of observation	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 Délai: 8th week of observation	White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.	8th week of observation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

María José Soto

Collaborateurs

Universidad de Granada

Les enquêteurs

Chercheur principal: Maria J. Soto-Méndez, MSc, Center for Studies of Sensory Impairment, Aging and Metabolism

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2012

Achèvement primaire (Réel)

1 novembre 2012

Achèvement de l'étude (Réel)