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

28 июля 2014 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Здоровый

Подробное описание

Please note protocol is also available in Spanish.

Тип исследования

Наблюдательный

Регистрация (Действительный)

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 1 год до 7 лет (Ребенок)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
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

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Weight Временное ограничение: 7th week of observation	Growth, measured trough weight (kg)	7th week of observation
Hemoglobin Временное ограничение: 8th week of observation	Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.	8th week of observation
Urine Osmolality-1 Временное ограничение: 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 Временное ограничение: 7th week of observation	Growth, measured trough height (cm).	7th week of observation
Urine Osmolality-2 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

María José Soto

Соавторы

Universidad de Granada

Следователи

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

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

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.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 июня 2012 г.

Первичное завершение (Действительный)

1 ноября 2012 г.

Завершение исследования (Действительный)