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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203890
• Other study ID #: CeSSIAM_02
• Status: Completed
• Phase: N/A
• First received: July 25, 2014
• Last updated: July 28, 2014
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: July 2014
• Source: Center for Studies of Sensory Impairment, Aging and Metabolism
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guatemala: Ministry of Public Health and Social Assistance
• Study type: Observational

Clinical Trial 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.

Description:

Please note protocol is also available in Spanish.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Months to 84 Months

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy
• Inflammation

Locations

Country	Name	City	State
Guatemala	Center for Studies of Sensory Impairment Aging and Metabolism	Guatemala	Quetzaltenango

Sponsors (2)

Lead Sponsor	Collaborator
María José Soto	Universidad de Granada

Country where clinical trial is conducted

Guatemala, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Growth, measured trough weight (kg)	7th week of observation	No
Primary	Hemoglobin	Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.	8th week of observation	No
Primary	Urine Osmolality-1	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	No
Primary	Height	Growth, measured trough height (cm).	7th week of observation	No
Primary	Urine Osmolality-2	Hydration Status= measured in 24-h urine through urine volume and osmolality Osmometer Model Löser 815. Results in mOsm/kg.	7th week of observation	No
Primary	Urine Osmolality-3	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	No
Primary	Urine Urea	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: urea (mg/l)	8th week of oservation	No
Primary	Urine Uric Acid	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: uric acid (mg/l)	8th week of oservation	No
Primary	Urine Sodium	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: sodium (mg/l)	8th week of oservation	No
Primary	Urine Potassium	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: potassium (mg/l)	8th week of oservation	No
Primary	Urine Calcium	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: calcium (mg/l)	8th week of oservation	No
Primary	Urine Magnesium	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: magnesium (mg/l)	8th week of oservation	No
Primary	Urine Phosphorus	Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: inorganic phosphorus (mg/l)	8th week of oservation	No
Primary	Urine 15-f2t-Isoprostanes	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	No
Primary	Urine 8-Hydroxydeoxyguanosine	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	No
Primary	Catalase Activity	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	No
Primary	Superoxide Dismutase Activity	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	No
Primary	Gluthathione Reductase	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	No
Primary	Gluthathione Peroxidase	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	No
Primary	Retinol	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.; Retinol (mg/dl)	8th week of observation	No
Primary	Alpha-tocopherol	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.; Alpha-tocopherol (mg/l)	8th week of observation	No
Primary	Beta-Carotenes	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.; Beta-carotenes (mg/l)	8th week of observation	No
Primary	Coenzyme Q9	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.; Coenzyme Q9 (mg/l)	8th week of observation	No
Primary	Coenzyme Q10	Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.; Coenzyme Q10 (mg/l)	8th week of observation	No
Primary	Plasma Interleukin-1B	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	No
Primary	Plasma Interleukin-6	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	No
Primary	Plasma Interleukin-8	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	No
Primary	Plasma Interleukin-10	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	No
Primary	Plasma Tumor Necrosis Factor-Alpha	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	No
Primary	Saliva Interleukin-1B	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	No
Primary	Saliva Interleukin-6	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	No
Primary	Saliva Interleukin-8	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	No
Primary	Saliva Interleukin-10	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	No
Primary	Saliva Tumor Necrosis Factor-Alpha	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	No
Primary	Fecal Calprotectin	Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).	8th week of observation	No
Primary	Intestinal Parasitosis	Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.	8th week of observation	No
Primary	Giardiasis Infection Presence-1	Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)	7th week of observation	No
Primary	Giardiasis Infection Presence-2	Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)	8th week of observation	No
Primary	White Urine Cell Count	White urine cell count (per field), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.	8th week of observation	Yes
Primary	White Blood Cell Count	White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.	8th week of observation	Yes