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

• ClinicalTrials.gov Identifier: NCT02203890
• Recruitment Status: Completed
• First Posted: July 30, 2014
• Last Update Posted: July 30, 2014
• Sponsor: María José Soto
• 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 *

• 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-Méndez MJ, Romero-Abal ME, Schümann K, Gil Á, 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-Méndez MJ, Aguilera CM, Campaña-Martín L, Martín-Laguna V, Schümann 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-Méndez MJ, Aguilera CM, Mesa MD, Campaña-Martín L, Martín-Laguna V, Solomons NW, Schümann K, Gil Á. 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.

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

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