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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02079961
Other study ID # EC CRP4 Senegal
Secondary ID
Status Completed
Phase Phase 0
First received May 21, 2013
Last updated March 5, 2014
Start date January 2013
Est. completion date March 2014

Study information

Verified date March 2014
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority Senegal: Ministere de la sante
Study type Interventional

Clinical Trial Summary

The study on dairy value chains that will be conducted in Northern Senegal tests whether a health-related product (micro-fortified yogurt) targeted to children can be provided through the logistics of an existing value chain, and whether in return this can be leveraged to enhance the reliability of producers supply within this value chain. This study is conducted with a local milk factory, a recently established social enterprise, striving to produce dairy products with the milk collected from several hundred semi-nomadic small-scale producers in northern Senegal. This study tests: (i) whether the logistic created to collect milk in a remote area can be leveraged to deliver fortified yogurts to infants within its suppliers households; (ii) whether such products effectively help improve the nutritional status (anemia) of these children; and (iii) whether these health services encourage suppliers (and in particular women) to increase their milk delivery to the milk factory.


Description:

Overall Objective

The overall study objectives are to better understand how a value chain can be made to be nutrition sensitive and ultimately leveraged to improve child nutrition, and to understand how certain incentives and services can be offered to actors within the value chain to enhance contractual relationships that strengthen the value chain.

In rural areas of developing countries where health products and services are poorly available, well organized agricultural value chains may be used to enhance access to such products and services to smallholder farmers. Yet, value chains in such countries face important challenges when it comes to enforcing contractual relationships, unless incentive-compatible schemes can be designed. As elsewhere, it may however be that health-related services themselves can, under certain conditions, serve as an adequate incentive towards more sustainable contractual relationships in the value chain.

Specific Objectives This study will address 2 key objectives.

1. To test whether an incentive in the form of a daily micronutrient-fortified yogurt for children can be used to increase milk supply during dry season and enhance contractual relationship between suppliers and agro-processors

2. To test whether the dairy value chain can be used as an efficient and sustainable means to supply essential micronutrients to young children, improve the quality of their diet and reduce anemia among young children during the one year duration of the intervention.

The study will focus on the particular case of a dairy value chain in Senegal, and will assess the extent to which micronutrient fortified yogurts can be used as a means to reduce the prevalence of anemia among infants and young children, and reinforce contractual arrangements between milk suppliers and a recently established social enterprise, the local milk factory.


Recruitment information / eligibility

Status Completed
Enrollment 471
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 24 Months to 59 Months
Eligibility Inclusion Criteria:

- All household that supplies milk to the milk factory and accept to enter in the study

- Household with at least one child aged 24 to 59 months old

Exclusion Criteria:

- Household with no children between 24 to 59 months old

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Micronutrient-fortified yoghurt
A iron-fortified yogurt targeted to children 24-59 months old will be provided through the logistics of an existing value chain, to see if in return this can enhance the reliability of producers supply within this value chain.
Behavioral:
BCC
Behavior Change Campaign (BCC) A behavior change campaign will be conducted during all the duration of the intervention to increase knowledge about good infant feeding practices and health.

Locations

Country Name City State
Senegal IFPRI Dakar

Sponsors (4)

Lead Sponsor Collaborator
Agnes LePort Cellule de Lutte contre la Malnutrition, GRET, Universite Gaston Berger

Country where clinical trial is conducted

Senegal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of anemia in children 24-59 months after receiving iron fortified yoghurt during a one year intervention The main outcome is the prevalence of anemia (hemoglobin below 11g/dl). Hemoglobin is measured in all children aged 24-59 months (by Hemocue analyzer) after a one year intervention at endline, in January 2014. one year Yes
Secondary Frequency of milk supply by pastoralist during one year intervention Frequency of milk supply by pastoralist that deliver milk to the milk factory during the one year intervention one year No
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