Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203890
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
Sponsor:
Collaborator:
Universidad de Granada
Information provided by (Responsible Party):
María José Soto, Center for Studies of Sensory Impairment, Aging and Metabolism

Tracking Information
First Submitted Date July 25, 2014
First Posted Date July 30, 2014
Last Update Posted Date July 30, 2014
Study Start Date June 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 28, 2014)
  • Weight [ Time Frame: 7th week of observation ]
    Growth, measured trough weight (kg)
  • Hemoglobin [ Time Frame: 8th week of observation ]
    Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
  • Urine Osmolality-1 [ Time Frame: 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.
  • Height [ Time Frame: 7th week of observation ]
    Growth, measured trough height (cm).
  • Urine Osmolality-2 [ Time Frame: 7th week of observation ]
    Hydration Status= measured in 24-h urine through urine volume and osmolality Osmometer Model Löser 815. Results in mOsm/kg.
  • Urine Osmolality-3 [ Time Frame: 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.
  • Urine Urea [ Time Frame: 8th week of oservation ]
    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: urea (mg/l)
  • Urine Uric Acid [ Time Frame: 8th week of oservation ]
    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: uric acid (mg/l)
  • Urine Sodium [ Time Frame: 8th week of oservation ]
    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: sodium (mg/l)
  • Urine Potassium [ Time Frame: 8th week of oservation ]
    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: potassium (mg/l)
  • Urine Calcium [ Time Frame: 8th week of oservation ]
    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: calcium (mg/l)
  • Urine Magnesium [ Time Frame: 8th week of oservation ]
    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: magnesium (mg/l)
  • Urine Phosphorus [ Time Frame: 8th week of oservation ]
    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: inorganic phosphorus (mg/l)
  • Urine 15-f2t-Isoprostanes [ Time Frame: 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)
  • Urine 8-Hydroxydeoxyguanosine [ Time Frame: 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).
  • Catalase Activity [ Time Frame: 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)
  • Superoxide Dismutase Activity [ Time Frame: 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)
  • Gluthathione Reductase [ Time Frame: 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)
  • Gluthathione Peroxidase [ Time Frame: 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)
  • Retinol [ Time Frame: 8th week of observation ]
    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Retinol (mg/dl)
  • Alpha-tocopherol [ Time Frame: 8th week of observation ]
    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Alpha-tocopherol (mg/l)
  • Beta-Carotenes [ Time Frame: 8th week of observation ]
    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Beta-carotenes (mg/l)
  • Coenzyme Q9 [ Time Frame: 8th week of observation ]
    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q9 (mg/l)
  • Coenzyme Q10 [ Time Frame: 8th week of observation ]
    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q10 (mg/l)
  • Plasma Interleukin-1B [ Time Frame: 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)
  • Plasma Interleukin-6 [ Time Frame: 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)
  • Plasma Interleukin-8 [ Time Frame: 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)
  • Plasma Interleukin-10 [ Time Frame: 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)
  • Plasma Tumor Necrosis Factor-Alpha [ Time Frame: 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)
  • Saliva Interleukin-1B [ Time Frame: 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)
  • Saliva Interleukin-6 [ Time Frame: 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)
  • Saliva Interleukin-8 [ Time Frame: 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)
  • Saliva Interleukin-10 [ Time Frame: 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)
  • Saliva Tumor Necrosis Factor-Alpha [ Time Frame: 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)
  • Fecal Calprotectin [ Time Frame: 8th week of observation ]
    Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).
  • Intestinal Parasitosis [ Time Frame: 8th week of observation ]
    Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.
  • Giardiasis Infection Presence-1 [ Time Frame: 7th week of observation ]
    Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
  • Giardiasis Infection Presence-2 [ Time Frame: 8th week of observation ]
    Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
  • White Urine Cell Count [ Time Frame: 8th week of observation ]
    White urine cell count (per field), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
  • White Blood Cell Count [ Time Frame: 8th week of observation ]
    White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children
Official Title 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
Brief Summary

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.
Detailed Description Please note protocol is also available in Spanish.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine, feces, saliva and blood
Sampling Method Non-Probability Sample
Study Population 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.
Condition Healthy
Intervention Not Provided
Study Groups/Cohorts 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 28, 2014)
91
Original Actual Enrollment Same as current
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 23 Months to 84 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Guatemala
Removed Location Countries  
 
Administrative Information
NCT Number NCT02203890
Other Study ID Numbers CeSSIAM_02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party María José Soto, Center for Studies of Sensory Impairment, Aging and Metabolism
Study Sponsor María José Soto
Collaborators Universidad de Granada
Investigators
Principal Investigator: Maria J. Soto-Méndez, MSc Center for Studies of Sensory Impairment, Aging and Metabolism
PRS Account Center for Studies of Sensory Impairment, Aging and Metabolism
Verification Date July 2014