Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

28 de julio de 2014 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Please note protocol is also available in Spanish.

Tipo de estudio

De observación

Inscripción (Actual)

91

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

1 año a 7 años (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Weight
Periodo de tiempo: 7th week of observation
Growth, measured trough weight (kg)
7th week of observation
Hemoglobin
Periodo de tiempo: 8th week of observation
Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
8th week of observation
Urine Osmolality-1
Periodo de tiempo: 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
Periodo de tiempo: 7th week of observation
Growth, measured trough height (cm).
7th week of observation
Urine Osmolality-2
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2012

Finalización primaria (Actual)

1 de noviembre de 2012

Finalización del estudio (Actual)

1 de noviembre de 2012

Fechas de registro del estudio

Enviado por primera vez

25 de julio de 2014

Primero enviado que cumplió con los criterios de control de calidad

28 de julio de 2014

Publicado por primera vez (Estimar)

30 de julio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

30 de julio de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

28 de julio de 2014

Última verificación

1 de julio de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CeSSIAM_02

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

3
Suscribir