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临床试验/NCT02160405
NCT02160405已完成3 期

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

Universidad Nacional de Colombia1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
212
试验地点
1
主要终点
Serum transferrin levels

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children from 2 to 5 years, beneficiaries of programs in institutional modality of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto

排除标准

  • Children who met inclusion criteria but are not allowed to participate, refuse systematically to the test or don't go regularly to the institution

结局指标

主要结局

Serum transferrin levels

时间窗: 11 weeks

serum ferritin leves

时间窗: 11 Weeks

次要结局

  • Haemoglobin(11 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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