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Effect on Iron Levels by the Inclusion of Native Potato in the Diet of Children From 2 to 5 Years, ICBF Beneficiaries. Nariño. Colombia. Cluster Randomized Controlled Trial
Effect on Iron Levels by the Inclusion of Native Potato in the Diet of Children From 2 to 5 Years, ICBF Beneficiaries in the Municipalities of Carlosama, Cumbal, Guachucal, Túquerres y Pasto. Nariño. Colombia. Cluster Randomized Controlled Trial
Nutritional deficiencies can lead to a number of health problems in children. In Latin America and the Caribbean countries, are registered so much problems of insufficient ingestion of food as of imbalances in the composition of the diet. These latter are expressed in the absence of micronutrients (iron, iodine, zinc, vitamin A), becoming a major health burden in developing countries. Being the globally's leading risk factor for disease and death, with hundreds of millions of pregnant women and young children particularly affected.
Justification: In Nariño, Colombia higher levels of malnutrition are presented with respect to country, just as micronutrient deficiency in children 1 to 4 years is higher than the national average. Most of these households are poor families with restrictions on access to food sources of these micronutrients, which is reported in a consumption of fruits, vegetables, milk products and meat, less than the national average. In this place is developing a project that aims to improve potato in higher yield, nutrition and resistance, for contribute to increase food security of native communities.
Objective: Evaluate the effect on iron levels generated by the inclusion of native potato in the diet of children aged 2-5 years in institutional beneficiaries modality ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto. Nariño. Colombia
Methods:
Design: A cluster randomized controlled trial. Open label Setting: 6 clusters, municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto (two towns), which will be randomly assigned to 2 groups: the treatment group that receives native potato, and the control group that receives traditional potato, that will be include in the usual Institution meal Participants: children from 2 to 5 years, beneficiaries of programs in institutional modality of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto.
Main outcome measures: serum ferritin and transferrin levels
The study was conducted in the form of institutional programs ICBF, in the municipalities of Carlosama, Guachucal, Túquerres, Cumbal and Pasto. Colombia. One hypothesis to a queue based on the changes that occur over time after surgery in the mean values (μ) of serum ferritin in the treatment group compared with the control group. A sample size of 212 children were calculated. The study has been presented and approved by the Ethics Committee of the Faculty of Medicine of the National University of Colombia and the Institutional Review Board of the participating institution. All parents of participating children must sign a written form to accept the voluntary participation of their child in the study.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Nariño
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Pasto, Nariño, Colombia
- Centros de Desarrollo Infantil Institucional
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- children from 2 to 5 years, beneficiaries of programs in institutional modality of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto
Exclusion Criteria:
- Children who met inclusion criteria but are not allowed to participate, refuse systematically to the test or don't go regularly to the institution
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Normaal dieet
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
serum ferritin leves
Tijdsspanne: 11 Weeks
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11 Weeks
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Serum transferrin levels
Tijdsspanne: 11 weeks
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11 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Haemoglobin
Tijdsspanne: 11 Weeks
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11 Weeks
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Weight
Tijdsspanne: 11 weeks
|
11 weeks
|
|
Height
Tijdsspanne: 11 Weeks
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Changes in Height over the time
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11 Weeks
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food intake
Tijdsspanne: 11 Weeks
|
Changes in food intake in the period
|
11 Weeks
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supplement of micronutrient
Tijdsspanne: 11 Weeks
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11 Weeks
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 74282013
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Klinische onderzoeken op native potato
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Emory UniversityVoltooid