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

2018年10月10日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (実際)

112

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Bogotá、コロンビア
        • Universidad Nacional de Colombia

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6ヶ月~5年 (子)

健康ボランティアの受け入れ

なし

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in hemoglobin concentration
時間枠:Baseline and after 12 months approximately
g/dL
Baseline and after 12 months approximately

二次結果の測定

結果測定
メジャーの説明
時間枠
Vitamin A (change in serum retinol concentration)
時間枠:Baseline and after 12 months approximately
μg / dL
Baseline and after 12 months approximately
Change in zinc concentration
時間枠:Baseline and after 12 months approximately
μg / dL
Baseline and after 12 months approximately
Change in transferrin concentration
時間枠:Baseline and after 12 months approximately
mg / dL
Baseline and after 12 months approximately
Change in ferritin concentration
時間枠:Baseline and after 12 months approximately
μg / L
Baseline and after 12 months approximately

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディディレクター:Sara E. Del Castillo Matamoros, Professor、Universidad Nacional de Colombia
  • スタディディレクター:Javier H. Eslava Schmalbach, Professor、Universidad Nacional de Colombia
  • 主任研究者:Nathalie Ospina Lizarazo, Student、Universidad Nacional de Colombia

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年7月7日

一次修了 (実際)

2017年11月26日

研究の完了 (実際)

2017年11月26日

試験登録日

最初に提出

2017年10月9日

QC基準を満たした最初の提出物

2017年10月16日

最初の投稿 (実際)

2017年10月18日

学習記録の更新

投稿された最後の更新 (実際)

2018年10月15日

QC基準を満たした最後の更新が送信されました

2018年10月10日

最終確認日

2018年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 37460

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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