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.

Study Overview

• Status: Completed
• Conditions: Effect on Iron Levels
• Intervention / Treatment: Dietary supplement: native potato

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

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Nariño
    • Pasto, Nariño, Colombia
      • Centros de Desarrollo Infantil Institucional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal diet	Dietary supplement: native potato

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum ferritin leves	11 Weeks
Serum transferrin levels	11 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Haemoglobin	11 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight		11 weeks
Height	Changes in Height over the time	11 Weeks
food intake	Changes in food intake in the period	11 Weeks
supplement of micronutrient		11 Weeks

Collaborators and Investigators

• Sponsor: Universidad Nacional de Colombia
• Collaborators: McGill University; Trade and Development Canada and Canadian International Development Agency (CIDA)

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Estimate): June 10, 2014
• Last Update Submitted That Met QC Criteria: June 6, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Iron levels
• Other Study ID Numbers: 74282013