- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02203890
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Quetzaltenango
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Guatemala, Quetzaltenango, Guatemala, 09001
- Center for Studies of Sensory Impairment Aging and Metabolism
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Weight
Periodo de tiempo: 7th week of observation
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Growth, measured trough weight (kg)
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7th week of observation
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Hemoglobin
Periodo de tiempo: 8th week of observation
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Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
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8th week of observation
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Urine Osmolality-1
Periodo de tiempo: 6th week of observation
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Hydration Status= measured in 24-h urine through urine volume and osmolality in osmometer Model Löser 815.
Results in mOsm/kg.
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6th week of observation
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Height
Periodo de tiempo: 7th week of observation
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Growth, measured trough height (cm).
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7th week of observation
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Urine Osmolality-2
Periodo de tiempo: 7th week of observation
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Hydration Status= measured in 24-h urine through urine volume and osmolality Osmometer Model Löser 815.
Results in mOsm/kg.
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7th week of observation
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Urine Osmolality-3
Periodo de tiempo: 8th week of observation
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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
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Urine Urea
Periodo de tiempo: 8th week of oservation
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Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: urea (mg/l) |
8th week of oservation
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Urine Uric Acid
Periodo de tiempo: 8th week of oservation
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Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: uric acid (mg/l) |
8th week of oservation
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Urine Sodium
Periodo de tiempo: 8th week of oservation
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Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: sodium (mg/l) |
8th week of oservation
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Urine Potassium
Periodo de tiempo: 8th week of oservation
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Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: potassium (mg/l) |
8th week of oservation
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Urine Calcium
Periodo de tiempo: 8th week of oservation
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Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: calcium (mg/l) |
8th week of oservation
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Urine Magnesium
Periodo de tiempo: 8th week of oservation
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Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: magnesium (mg/l) |
8th week of oservation
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Urine Phosphorus
Periodo de tiempo: 8th week of oservation
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Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: inorganic phosphorus (mg/l) |
8th week of oservation
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Urine 15-f2t-Isoprostanes
Periodo de tiempo: 8th week of observation
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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
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Urine 8-Hydroxydeoxyguanosine
Periodo de tiempo: 8th week of observation
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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
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Catalase Activity
Periodo de tiempo: 8th week of observation
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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
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Superoxide Dismutase Activity
Periodo de tiempo: 8th week of observation
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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)
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8th week of observation
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Gluthathione Reductase
Periodo de tiempo: 8th week of observation
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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)
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8th week of observation
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Gluthathione Peroxidase
Periodo de tiempo: 8th week of observation
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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)
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8th week of observation
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Retinol
Periodo de tiempo: 8th week of observation
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Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Retinol (mg/dl) |
8th week of observation
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Alpha-tocopherol
Periodo de tiempo: 8th week of observation
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Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Alpha-tocopherol (mg/l) |
8th week of observation
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Beta-Carotenes
Periodo de tiempo: 8th week of observation
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Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Beta-carotenes (mg/l) |
8th week of observation
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Coenzyme Q9
Periodo de tiempo: 8th week of observation
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Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q9 (mg/l) |
8th week of observation
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Coenzyme Q10
Periodo de tiempo: 8th week of observation
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Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q10 (mg/l) |
8th week of observation
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Plasma Interleukin-1B
Periodo de tiempo: 8th week of observation
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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
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Plasma Interleukin-6
Periodo de tiempo: 8th week of observation
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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
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Plasma Interleukin-8
Periodo de tiempo: 8th week of observation
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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
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Plasma Interleukin-10
Periodo de tiempo: 8th week of observation
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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
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Plasma Tumor Necrosis Factor-Alpha
Periodo de tiempo: 8th week of observation
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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
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Saliva Interleukin-1B
Periodo de tiempo: 8th week of observation
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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)
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8th week of observation
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Saliva Interleukin-6
Periodo de tiempo: 8th week of observation
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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)
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8th week of observation
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Saliva Interleukin-8
Periodo de tiempo: 8th week of observation
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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)
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8th week of observation
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Saliva Interleukin-10
Periodo de tiempo: 8th week of observation
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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)
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8th week of observation
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Saliva Tumor Necrosis Factor-Alpha
Periodo de tiempo: 8th week of observation
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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
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Fecal Calprotectin
Periodo de tiempo: 8th week of observation
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Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).
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8th week of observation
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Intestinal Parasitosis
Periodo de tiempo: 8th week of observation
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Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala.
Parasite cysts presence in feces.
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8th week of observation
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Giardiasis Infection Presence-1
Periodo de tiempo: 7th week of observation
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Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
|
7th week of observation
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Giardiasis Infection Presence-2
Periodo de tiempo: 8th week of observation
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Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
|
8th week of observation
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White Urine Cell Count
Periodo de tiempo: 8th week of observation
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White urine cell count (per field), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
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8th week of observation
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White Blood Cell Count
Periodo de tiempo: 8th week of observation
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White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
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8th week of observation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maria J. Soto-Méndez, MSc, Center for Studies of Sensory Impairment, Aging and Metabolism
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CeSSIAM_02
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