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OpenTrials
Completed

NCT Number: NCT02203890

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

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.

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Key information

Conditions

Healthy Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

23 month–84 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Studies of Sensory Impairment Aging and Metabolism

Guatemala, Departamento de Quetzaltenango, 09001

About this study

Please note protocol is also available in Spanish.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Weight

    Time frame: 7th week of observation

    Growth, measured trough weight (kg)

  2. Hemoglobin

    Time frame: 8th week of observation

    Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.

  3. 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.

  4. Height

    Time frame: 7th week of observation

    Growth, measured trough height (cm).

  5. 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.

  6. 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.

  7. Urine Urea

    Time frame: 8th week of oservation

    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:

    urea (mg/l)

  8. 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)

  9. Urine Sodium

    Time frame: 8th week of oservation

    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:

    sodium (mg/l)

  10. Urine Potassium

    Time frame: 8th week of oservation

    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:

    potassium (mg/l)

  11. Urine Calcium

    Time frame: 8th week of oservation

    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:

    calcium (mg/l)

  12. Urine Magnesium

    Time frame: 8th week of oservation

    Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:

    magnesium (mg/l)

  13. 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)

  14. 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)

  15. 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).

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. Retinol

    Time frame: 8th week of observation

    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.

    Retinol (mg/dl)

  21. Alpha-tocopherol

    Time frame: 8th week of observation

    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.

    Alpha-tocopherol (mg/l)

  22. Beta-Carotenes

    Time frame: 8th week of observation

    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.

    Beta-carotenes (mg/l)

  23. Coenzyme Q9

    Time frame: 8th week of observation

    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.

    Coenzyme Q9 (mg/l)

  24. Coenzyme Q10

    Time frame: 8th week of observation

    Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.

    Coenzyme Q10 (mg/l)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. 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)

  31. 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)

  32. 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)

  33. 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)

  34. 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)

  35. Fecal Calprotectin

    Time frame: 8th week of observation

    Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).

  36. Intestinal Parasitosis

    Time frame: 8th week of observation

    Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.

  37. Giardiasis Infection Presence-1

    Time frame: 7th week of observation

    Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)

  38. Giardiasis Infection Presence-2

    Time frame: 8th week of observation

    Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)

  39. 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.

  40. 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.

Sponsors and collaborators

Lead sponsor

María José Soto

Other

Collaborators

  • Universidad de Granada

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 30, 2014
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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