HealthyNCT02203890
Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children
An observational study of Healthy, run by María José Soto at 1 site in Guatemala.
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. Read more about this study
- Who is it for?
- Ages 23 to 84 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 91 participants
- Where
- 1 siteGuatemala
- Study dates
- Jun 2012to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 84 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Guatemala1 site
Center for Studies of Sensory Impairment Aging and Metabolism
Guatemala, Departamento de Quetzaltenango, 09001
About this study
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
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.
Read more
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.
Read the detailed description
Please note protocol is also available in Spanish.
- Conditions
- Healthy
- Keywords
- Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan children
- Medical subject headings
- Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Growth, measured trough weight (kg)
Measured: 7th week of observation
Hemoglobin
Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
Measured: 8th week of observation
Urine Osmolality-1
Hydration Status= measured in 24-h urine through urine volume and osmolality in osmometer Model Löser 815. Results in mOsm/kg.
Measured: 6th week of observation
Height
Growth, measured trough height (cm).
Measured: 7th week of observation
Urine Osmolality-2
Hydration Status= measured in 24-h urine through urine volume and osmolality Osmometer Model Löser 815. Results in mOsm/kg.
Measured: 7th week of observation
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.
Measured: 8th week of observation
Urine Urea
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
urea (mg/l)
Measured: 8th week of oservation
Urine Uric Acid
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
uric acid (mg/l)
Measured: 8th week of oservation
Urine Sodium
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
sodium (mg/l)
Measured: 8th week of oservation
Urine Potassium
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
potassium (mg/l)
Measured: 8th week of oservation
Urine Calcium
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
calcium (mg/l)
Measured: 8th week of oservation
Urine Magnesium
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
magnesium (mg/l)
Measured: 8th week of oservation
Urine Phosphorus
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
inorganic phosphorus (mg/l)
Measured: 8th week of oservation
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)
Measured: 8th week of observation
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).
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
Retinol
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Retinol (mg/dl)
Measured: 8th week of observation
Alpha-tocopherol
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Alpha-tocopherol (mg/l)
Measured: 8th week of observation
Beta-Carotenes
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Beta-carotenes (mg/l)
Measured: 8th week of observation
Coenzyme Q9
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Coenzyme Q9 (mg/l)
Measured: 8th week of observation
Coenzyme Q10
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Coenzyme Q10 (mg/l)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
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)
Measured: 8th week of observation
Fecal Calprotectin
Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).
Measured: 8th week of observation
Intestinal Parasitosis
Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.
Measured: 8th week of observation
Giardiasis Infection Presence-1
Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
Measured: 7th week of observation
Giardiasis Infection Presence-2
Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
Measured: 8th week of observation
White Urine Cell Count
White urine cell count (per field), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
Measured: 8th week of observation
White Blood Cell Count
White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
Measured: 8th week of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- María José Soto
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada
- Responsible party
- Sponsor-investigator, María José Soto, Center for Studies of Sensory Impairment, Aging and Metabolism
- Investigators
- Maria J. Soto-Méndez, MSc, Principal investigator, Center for Studies of Sensory Impairment, Aging and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203890
- Sponsor's protocol ID
- CeSSIAM_02
- Status last verified
- Jul 2014
- First submitted
- 25 Jul 2014
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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-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.
PubMed 27101538Soto-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.
PubMed 26269363Soto-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.
PubMed 26111297
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02203890
- Acronym / sponsor ID
- CeSSIAM_02
- Conditions
- Healthy
- Keywords
- Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- María José SotoUniversity, hospital or other
- Collaborators
- Universidad de Granada
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 23 to 84 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
- Results publicationSoto-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.
- Derived from this study: PubMed 27101538Soto-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.
- Derived from this study: PubMed 26269363Soto-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.
- Derived from this study: PubMed 26111297Soto-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria J. Soto-Méndez, MSc principal investigator
Center for Studies of Sensory Impairment, Aging and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by María José Soto at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 7th week of observation). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02203890, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.