Clinical trial NCT03313089: Nutritional Impact of a Project on Food Security and Nutrition in Children Receiving Micronutrient Powders in Colombia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemoglobin
Anemia
Keywords: micronutrient powders
spinkles
nutrition
food security program
nutritional program
hemoglobin
anemia
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
Collaborators: name: International Development Research Centre, Canada
name: McGill University
First posted: 2017-10-18
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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,

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.

Detailed description: Micronutrient deficiency is a public health problem. At the national level according to ENSIN 2010, in Colombia the prevalence of anemia in children of 6 to 59 months is 27.5%; of 24.3% for vitamin A deficiency in children between 1 and 4 years of age; and in the case of zinc deficiency, the prevalence is of 43.3% of children under 5 years of age. According to FAO and WHO, different strategies for overcoming micronutrient deficiencies need to be combined and balanced in order to achieve maximum impact.

The project "Papas más nutritivas" ("Ampliación de la producción de papas amarillas más nutritivas en Colombia (CIFSRF phase 2) / Scaling up synergetic strategies in agriculture and nutrition in rural communities of Colombia") funded by the IDRC-International Development Research Center, through the Canadian International Food Security Research Fund (CISFR) and implemented by the McGILL University Canada and the Universidad Nacional de Colombia involve, in addition to the expansion of production of the new varieties of yellow potatoes, other activities such as Community Schools of Family Agriculture, training schools of leader and managers in sovereignty and food and nutritional security, strengthening of the shagra (home garden) and home fortification with micronutrients powders, seeking to improve the quality of life and nutritional status of families of potato producers for the scope of the food and nutritional security.

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.

Objective: To establish the existence of difference in hemoglobin values 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.

Methodology: Prospective cohort. Two groups are established: the first, children exposed to the activities of the project "Papas más nutritivas" + MNP (PSAN+MNP group) , and the second, children exposed only to MNP (MNP group). We will try to include 140 children (70 for each of the groups), this sample gives us a power of 90% to find a delta of 0.5.

Blood samples will be obtained to evaluate the biochemical parameters: Hemoglobin (determined by HemoCue), Ferritin, Transferrin, Zinc, vitamin A, C-reactive-ultrasensitive protein, before MNP fortification and when it finished.

For statistical analysis, a descriptive analysis of both PSAN + MNP and MNP groups will be carried out on sociodemographic variables, health status and nutritional status. The continuous variables will be expressed with their measures of central tendency and dispersion, for the categorical variables absolute and relative frequencies will be used. The hypothesis of equality of pre and post treatment hemoglobin differences between the groups (PSAN + MNP versus MNP) will be analyzed using a Student t test or Mann Whitney test, depending on whether the data follow a normal distribution. A statistically significant p value corresponding to 0.05 will be considered. The other secondary outcome variables (vitamin A, zinc, ferritin, transferrin) will be similarly analyzed. In order to control the systematic differences in the baseline characteristics between the intervention and control groups, it is proposed to use Propensity Score, which will include the variables of sex, age and other sociodemographic and nutritional variables considered potentially confusing. The score of the propensity score model will be used as a covariate in a linear regression model where it will be adjusted further by the pre-test values of the intervention (ANCOVA). An unadjusted preliminary analysis (initially described) will be presented and then a new analysis with the proposed adjustment. An additional analysis will be performed for the ferritin variable excluding patients with high CRP values.

Eligibility 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.

Primary outcomes:
measure: Change in hemoglobin concentration
timeFrame: Baseline and after 12 months approximately
Secondary outcomes:
measure: Vitamin A (change in serum retinol concentration)
timeFrame: Baseline and after 12 months approximately
measure: Change in zinc concentration
timeFrame: Baseline and after 12 months approximately
measure: Change in transferrin concentration
timeFrame: Baseline and after 12 months approximately
measure: Change in ferritin concentration
timeFrame: Baseline and after 12 months approximately
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Universidad Nacional de Colombia
Study officials:
affiliation: Universidad Nacional de Colombia
name: Sara E. Del Castillo Matamoros, Professor
role: STUDY_DIRECTOR
affiliation: Universidad Nacional de Colombia
name: Javier H. Eslava Schmalbach, Professor
role: STUDY_DIRECTOR
affiliation: Universidad Nacional de Colombia
name: Nathalie Ospina Lizarazo, Student
role: PRINCIPAL_INVESTIGATOR
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