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

2014年7月28日 更新者: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.

研究概览

地位

完全的

条件

详细说明

Please note protocol is also available in Spanish.

研究类型

观察性的

注册 (实际的)

91

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Quetzaltenango
      • Guatemala、Quetzaltenango、危地马拉、09001
        • Center for Studies of Sensory Impairment Aging and Metabolism

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1年 至 7年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Weight
大体时间:7th week of observation
Growth, measured trough weight (kg)
7th week of observation
Hemoglobin
大体时间:8th week of observation
Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
8th week of observation
Urine Osmolality-1
大体时间: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
大体时间:7th week of observation
Growth, measured trough height (cm).
7th week of observation
Urine Osmolality-2
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Maria J. Soto-Méndez, MSc、Center for Studies of Sensory Impairment, Aging and Metabolism

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年6月1日

初级完成 (实际的)

2012年11月1日

研究完成 (实际的)

2012年11月1日

研究注册日期

首次提交

2014年7月25日

首先提交符合 QC 标准的

2014年7月28日

首次发布 (估计)

2014年7月30日

研究记录更新

最后更新发布 (估计)

2014年7月30日

上次提交的符合 QC 标准的更新

2014年7月28日

最后验证

2014年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CeSSIAM_02

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