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
Condition: Effect on Iron Levels
Study type: Interventional
Phase: Phase 3

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.
    

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
    

Intervention name(s): native potato
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Iron levels