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Nutritional Impact of a Project on Food Security and Nutrition in Children Receiving Micronutrient Powders in Colombia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03313089
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
International Development Research Centre, Canada
McGill University
Information provided by (Responsible Party):
Nathalie Ospina, Universidad Nacional de Colombia

Brief Summary:

The effectiveness of micronutrient powders or MNP as a strategy for the prevention of micronutrient deficiencies has been described in the literature. However, few studies have shown the impact of the inclusion of other simultaneous actions on the different dimensions of food and nutritional security (as in the case of the project "Papas más nutritivas") that will contribute to the improvement of nutritional status, obtaining potentially greater benefits.

The objective is to establish the existence of difference in hemoglobin values (and other biochemical parameters as secondary outcomes) among children aged 6 months to 5 years who receive home fortification with micronutrient powders (MNP) belonging to the project "Papas más nutritivas", and children with home fortification with MNP but not belonging to the project.


Condition or disease Intervention/treatment
Hemoglobin Anemia Behavioral: "Papas más nutritivas" (PSAN)

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Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nutritional Impact of a Project on Food Security and Nutrition in Children of 6 Months to 5 Years of Age Receiving Home Fortification With Micronutrient Powders in Nariño, Colombia
Actual Study Start Date : July 7, 2017
Actual Primary Completion Date : November 26, 2017
Actual Study Completion Date : November 26, 2017

Group/Cohort Intervention/treatment
PSAN + MNP

PSAN ("Papas más nutritivas" project) + MNP (micronutrients powders):

Children of the families beneficiaries of Community Schools of Family Agriculture of the municipalities of Cumbal, Carlosama Guachucal and Túquerres, who are part of the project "Papas más nutritivas" and exposed to project activities in which they work on topics related to food and nutritional security, equity and gender, production and entrepreneurship, Additionally, the home fortification with MNP that is 12 months in total approximately, will be made 2 deliveries of 60 doses (specified in the "MNP only" group). After the delivery of MNP, advising, measurements of weight and height, clarification of doubts regarding fortification with MNP, nutrition education, and accompaniment by the project staff will take place.

Behavioral: "Papas más nutritivas" (PSAN)
Activities of the project "Papas más nutritivas"

MNP only

Cohort of exposed to MNP (micronutrients powders):

Children who will receive MNP delivered through the hospital or institutional health service providers of the municipalities of Guachucal and Carlosama, following the protocol for the home fortification with MNP that is 12 months in total approximately, will be made 2 deliveries of 60 doses: the first period consists of the taking of MNP for 2 months, followed by a rest period of 4 months and continues again by another MNP intake for 2 months and rest for 4 months, and exposed to dissemination of basic information with regard to MNP and monitoring by growth and development that is routinely performed by health staff.




Primary Outcome Measures :
  1. Change in hemoglobin concentration [ Time Frame: Baseline and after 12 months approximately ]
    g/dL


Secondary Outcome Measures :
  1. Vitamin A (change in serum retinol concentration) [ Time Frame: Baseline and after 12 months approximately ]
    μg / dL

  2. Change in zinc concentration [ Time Frame: Baseline and after 12 months approximately ]
    μg / dL

  3. Change in transferrin concentration [ Time Frame: Baseline and after 12 months approximately ]
    mg / dL

  4. Change in ferritin concentration [ Time Frame: Baseline and after 12 months approximately ]
    μg / L



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Boys and girls of 6 months to 5 years of age inhabitants of municipalities: Carlosama, Guachucal, Túquerres and Cumbal in the department of Nariño,
Criteria

Inclusion Criteria:

  • Boys and girls of 6 months to 5 years of age receiving home fortification with micronutrient powders.

Exclusion Criteria:

  • Children who are consuming nutritional complements or supplements.
  • Children undergoing treatment for anemia or other micronutrient deficiencies.

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): NCT03313089


Locations
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Colombia
Universidad Nacional de Colombia
Bogotá, Colombia
Sponsors and Collaborators
Universidad Nacional de Colombia
International Development Research Centre, Canada
McGill University
Investigators
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Study Director: Sara E. Del Castillo Matamoros, Professor Universidad Nacional de Colombia
Study Director: Javier H. Eslava Schmalbach, Professor Universidad Nacional de Colombia
Principal Investigator: Nathalie Ospina Lizarazo, Student Universidad Nacional de Colombia

Additional Information:
Publications:
Ministerio De Salud y Protección Social. Estrategia Nacional para la Prevención y Control de las Deficiencias de Micronutrientes en Colombia 2014 - 2021. Bogotá D.C., Colombia. 2015.
World Health Organization and Food and Agriculture Organization of the United Nations. Guidelines on Food Fortification with Micronutrients. Editado por Lindsay Allen y cols.
Ministerio de la Protección Social. Instituto Colombiano de Bienestar Familiar. ENSIN 2010- Encuesta Nacional de Situación Nutricional en Colombia 2010. Ed. Bogotá: 2011.
OMS. Directriz: Uso de micronutrientes en polvo para la fortificación domiciliaria de los alimentos consumidos por lactantes y niños de 6 a 23 meses de edad. Ginebra, Organización Mundial de la Salud, 2012.
Del Castillo SE, Mosquera T, Suárez EL, Heredia P. Nutritional Situation of Rural Communities in Nariño, Colombia 2013. Food and Nutrition Sciences (5): 1521-1528, 2014

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Responsible Party: Nathalie Ospina, Master Student, Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT03313089    
Other Study ID Numbers: 37460
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nathalie Ospina, Universidad Nacional de Colombia:
micronutrient powders
spinkles
nutrition
food security program
nutritional program
hemoglobin
anemia
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs