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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

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ClinicalTrials.gov Identifier: NCT02160405
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : June 10, 2014
Sponsor:
Collaborators:
McGill University
Trade and Development Canada and Canadian International Development Agency (CIDA)
Information provided by (Responsible Party):
Universidad Nacional de Colombia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Effect on Iron Levels Dietary Supplement: native potato Phase 3

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : February 2014
Actual Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Normal diet Dietary Supplement: native potato



Primary Outcome Measures :
  1. serum ferritin leves [ Time Frame: 11 Weeks ]
  2. Serum transferrin levels [ Time Frame: 11 weeks ]

Secondary Outcome Measures :
  1. Haemoglobin [ Time Frame: 11 Weeks ]

Other Outcome Measures:
  1. Weight [ Time Frame: 11 weeks ]
  2. Height [ Time Frame: 11 Weeks ]
    Changes in Height over the time

  3. food intake [ Time Frame: 11 Weeks ]
    Changes in food intake in the period

  4. supplement of micronutrient [ Time Frame: 11 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160405


Locations
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Colombia
Centros de Desarrollo Infantil Institucional
Pasto, Nariño, Colombia
Sponsors and Collaborators
Universidad Nacional de Colombia
McGill University
Trade and Development Canada and Canadian International Development Agency (CIDA)
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Responsible Party: Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT02160405    
Other Study ID Numbers: 74282013
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014
Keywords provided by Universidad Nacional de Colombia:
Iron levels