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

10. oktober 2018 oppdatert av: Nathalie Ospina, Universidad Nacional de Colombia

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

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

112

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Bogotá, Colombia
        • Universidad Nacional de Colombia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 måneder til 5 år (Barn)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Boys and girls of 6 months to 5 years of age inhabitants of municipalities: Carlosama, Guachucal, Túquerres and Cumbal in the department of Nariño,

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in hemoglobin concentration
Tidsramme: Baseline and after 12 months approximately
g/dL
Baseline and after 12 months approximately

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Vitamin A (change in serum retinol concentration)
Tidsramme: Baseline and after 12 months approximately
μg / dL
Baseline and after 12 months approximately
Change in zinc concentration
Tidsramme: Baseline and after 12 months approximately
μg / dL
Baseline and after 12 months approximately
Change in transferrin concentration
Tidsramme: Baseline and after 12 months approximately
mg / dL
Baseline and after 12 months approximately
Change in ferritin concentration
Tidsramme: Baseline and after 12 months approximately
μg / L
Baseline and after 12 months approximately

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Sara E. Del Castillo Matamoros, Professor, Universidad Nacional de Colombia
  • Studieleder: Javier H. Eslava Schmalbach, Professor, Universidad Nacional de Colombia
  • Hovedetterforsker: Nathalie Ospina Lizarazo, Student, Universidad Nacional de Colombia

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. juli 2017

Primær fullføring (Faktiske)

26. november 2017

Studiet fullført (Faktiske)

26. november 2017

Datoer for studieregistrering

Først innsendt

9. oktober 2017

Først innsendt som oppfylte QC-kriteriene

16. oktober 2017

Først lagt ut (Faktiske)

18. oktober 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 37460

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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