ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT02203890
Date of registration:	25/07/2014
Prospective Registration:	No
Primary sponsor:	María José Soto
Public title:	Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children
Scientific 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
Date of first enrolment:	June 2012
Target sample size:	91
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT02203890
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Cross-Sectional
Phase:	N/A

Countries of recruitment
Guatemala

Contacts

Name:	Maria J. Soto-Méndez, MSc
Address:
Telephone:
Email:
Affiliation:	Center for Studies of Sensory Impairment, Aging and Metabolism

Key inclusion & exclusion 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.

Age minimum: 23 Months
Age maximum: 84 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Primary Outcome(s)

Catalase Activity [Time Frame: 8th week of observation]

Coenzyme Q10 [Time Frame: 8th week of observation]

Hemoglobin [Time Frame: 8th week of observation]

Plasma Interleukin-1B [Time Frame: 8th week of observation]

Plasma Interleukin-8 [Time Frame: 8th week of observation]

Superoxide Dismutase Activity [Time Frame: 8th week of observation]

Urine 15-f2t-Isoprostanes [Time Frame: 8th week of observation]

Urine Calcium [Time Frame: 8th week of oservation]

Beta-Carotenes [Time Frame: 8th week of observation]

Gluthathione Reductase [Time Frame: 8th week of observation]

Plasma Interleukin-6 [Time Frame: 8th week of observation]

Plasma Tumor Necrosis Factor-Alpha [Time Frame: 8th week of observation]

Saliva Interleukin-6 [Time Frame: 8th week of observation]

Saliva Interleukin-8 [Time Frame: 8th week of observation]

Weight [Time Frame: 7th week of observation]

Giardiasis Infection Presence-2 [Time Frame: 8th week of observation]

Urine Osmolality-1 [Time Frame: 6th week of observation]

Plasma Interleukin-10 [Time Frame: 8th week of observation]

Urine Sodium [Time Frame: 8th week of oservation]

Coenzyme Q9 [Time Frame: 8th week of observation]

Gluthathione Peroxidase [Time Frame: 8th week of observation]

Giardiasis Infection Presence-1 [Time Frame: 7th week of observation]

Urine Phosphorus [Time Frame: 8th week of oservation]

Urine Potassium [Time Frame: 8th week of oservation]

Urine Urea [Time Frame: 8th week of oservation]

Intestinal Parasitosis [Time Frame: 8th week of observation]

Retinol [Time Frame: 8th week of observation]

Saliva Interleukin-10 [Time Frame: 8th week of observation]

Urine 8-Hydroxydeoxyguanosine [Time Frame: 8th week of observation]

Alpha-tocopherol [Time Frame: 8th week of observation]

Height [Time Frame: 7th week of observation]

Urine Magnesium [Time Frame: 8th week of oservation]

White Urine Cell Count [Time Frame: 8th week of observation]

Fecal Calprotectin [Time Frame: 8th week of observation]

Saliva Tumor Necrosis Factor-Alpha [Time Frame: 8th week of observation]

Saliva Interleukin-1B [Time Frame: 8th week of observation]

Urine Osmolality-3 [Time Frame: 8th week of observation]

Urine Uric Acid [Time Frame: 8th week of oservation]

White Blood Cell Count [Time Frame: 8th week of observation]

Urine Osmolality-2 [Time Frame: 7th week of observation]

Secondary Outcome(s)

Secondary ID(s)

CeSSIAM_02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universidad de Granada

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.