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

2014년 7월 28일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

Please note protocol is also available in Spanish.

연구 유형

관찰

등록 (실제)

91

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1년 (어린이)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Weight
기간: 7th week of observation
Growth, measured trough weight (kg)
7th week of observation
Hemoglobin
기간: 8th week of observation
Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
8th week of observation
Urine Osmolality-1
기간: 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
기간: 7th week of observation
Growth, measured trough height (cm).
7th week of observation
Urine Osmolality-2
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 6월 1일

기본 완료 (실제)

2012년 11월 1일

연구 완료 (실제)

2012년 11월 1일

연구 등록 날짜

최초 제출

2014년 7월 25일

QC 기준을 충족하는 최초 제출

2014년 7월 28일

처음 게시됨 (추정)

2014년 7월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 7월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 7월 28일

마지막으로 확인됨

2014년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CeSSIAM_02

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