Clinical trial NCT02203890: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Growth
Hematology
Hydration
Oxidation
Infection
Inflammation
Guatemalan children
Lead sponsor: Center for Studies of Sensory Impairment, Aging and Metabolism
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
First posted: 2014-07-30
Enrollment: 91
Sex: ALL
Minimum age (years): 23
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Weight
timeFrame: 7th week of observation
measure: Hemoglobin
timeFrame: 8th week of observation
measure: Urine Osmolality-1
timeFrame: 6th week of observation
measure: Height
timeFrame: 7th week of observation
measure: Urine Osmolality-2
timeFrame: 7th week of observation
measure: Urine Osmolality-3
timeFrame: 8th week of observation
measure: Urine Urea
timeFrame: 8th week of oservation
measure: Urine Uric Acid
timeFrame: 8th week of oservation
measure: Urine Sodium
timeFrame: 8th week of oservation
measure: Urine Potassium
timeFrame: 8th week of oservation
measure: Urine Calcium
timeFrame: 8th week of oservation
measure: Urine Magnesium
timeFrame: 8th week of oservation
measure: Urine Phosphorus
timeFrame: 8th week of oservation
measure: Urine 15-f2t-Isoprostanes
timeFrame: 8th week of observation
measure: Urine 8-Hydroxydeoxyguanosine
timeFrame: 8th week of observation
measure: Catalase Activity
timeFrame: 8th week of observation
measure: Superoxide Dismutase Activity
timeFrame: 8th week of observation
measure: Gluthathione Reductase
timeFrame: 8th week of observation
measure: Gluthathione Peroxidase
timeFrame: 8th week of observation
measure: Retinol
timeFrame: 8th week of observation
measure: Alpha-tocopherol
timeFrame: 8th week of observation
measure: Beta-Carotenes
timeFrame: 8th week of observation
measure: Coenzyme Q9
timeFrame: 8th week of observation
measure: Coenzyme Q10
timeFrame: 8th week of observation
measure: Plasma Interleukin-1B
timeFrame: 8th week of observation
measure: Plasma Interleukin-6
timeFrame: 8th week of observation
measure: Plasma Interleukin-8
timeFrame: 8th week of observation
measure: Plasma Interleukin-10
timeFrame: 8th week of observation
measure: Plasma Tumor Necrosis Factor-Alpha
timeFrame: 8th week of observation
measure: Saliva Interleukin-1B
timeFrame: 8th week of observation
measure: Saliva Interleukin-6
timeFrame: 8th week of observation
measure: Saliva Interleukin-8
timeFrame: 8th week of observation
measure: Saliva Interleukin-10
timeFrame: 8th week of observation
measure: Saliva Tumor Necrosis Factor-Alpha
timeFrame: 8th week of observation
measure: Fecal Calprotectin
timeFrame: 8th week of observation
measure: Intestinal Parasitosis
timeFrame: 8th week of observation
measure: Giardiasis Infection Presence-1
timeFrame: 7th week of observation
measure: Giardiasis Infection Presence-2
timeFrame: 8th week of observation
measure: White Urine Cell Count
timeFrame: 8th week of observation
measure: White Blood Cell Count
timeFrame: 8th week of observation
Secondary outcomes:
Other outcomes:
Locations:
city: Guatemala
country: Guatemala
facility: Center for Studies of Sensory Impairment Aging and Metabolism
state: Quetzaltenango
Study officials:
affiliation: Center for Studies of Sensory Impairment, Aging and Metabolism
name: Maria J. Soto-Méndez, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Soto-Mendez MJ, Romero-Abal ME, Schumann K, Gil A, 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.
citation: Soto-Mendez MJ, Aguilera CM, Campana-Martin L, Martin-Laguna V, Schumann 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.
citation: Soto-Mendez MJ, Aguilera CM, Mesa MD, Campana-Martin L, Martin-Laguna V, Solomons NW, Schumann K, Gil A. 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.