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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.

調査の概要

状態

完了

条件

詳細な説明

Please note protocol is also available in Spanish.

研究の種類

観察的

入学 (実際)

91

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Quetzaltenango
      • Guatemala、Quetzaltenango、グアテマラ、09001
        • Center for Studies of Sensory Impairment Aging and Metabolism

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1年~7年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Weight
時間枠:7th week of observation
Growth, measured trough weight (kg)
7th week of observation
Hemoglobin
時間枠:8th week of observation
Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
8th week of observation
Urine Osmolality-1
時間枠: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
時間枠:7th week of observation
Growth, measured trough height (cm).
7th week of observation
Urine Osmolality-2
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Maria J. Soto-Méndez, MSc、Center for Studies of Sensory Impairment, Aging and Metabolism

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年6月1日

一次修了 (実際)

2012年11月1日

研究の完了 (実際)

2012年11月1日

試験登録日

最初に提出

2014年7月25日

QC基準を満たした最初の提出物

2014年7月28日

最初の投稿 (見積もり)

2014年7月30日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年7月30日

QC基準を満たした最後の更新が送信されました

2014年7月28日

最終確認日

2014年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CeSSIAM_02

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