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

M

María José Soto

Status

Completed

Conditions

Healthy

Study type

Observational

Funder types

Other

Identifiers

NCT02203890
CeSSIAM_02

Details and patient eligibility

About

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.

Full description

Please note protocol is also available in Spanish.

Enrollment

91 patients

Sex

All

Ages

23 to 84 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

91 participants in 1 patient group

Apparently Healthy
Description:
Apparently healthy preschool children who attend 3 daycare centers of the Secretariat of Beneficials Works of the First Lady in Guatemalan Western Highlands

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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