AnemiaEarly Phase 1NCT02079961
Distribution of Fortified Yoghurt in Senegal to Decrease Children's Anemia and Improve Milk Supply
A Early Phase 1 study testing Micronutrient-fortified yoghurt and BCC in people with Anemia and Iron-Deficiency, run by Agnes LePort at 1 site in Senegal.
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… Read more about this study
- Who is it for?
- Ages 24 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-Deficiency
- What is being tested?
- Micronutrient-fortified yoghurt and BCC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteSenegal
- Study dates
- Jan 2013to Mar 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Household with no children between 24 to 59 months old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Nutrition Through Agricultural Contracts; Better Contracts Through Nutrition Incentives: A Case Study of Utilizing a Dairy Value Chain in Northern Senegal to Reduce Anemia and Improve Milk Supply
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.
Read the detailed 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.
- 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
- 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.
- Conditions
- Anemia, Iron-Deficiency
- Being tested
- Micronutrient-fortified yoghurt, BCC
- Keywords
- anemia, children, iron-fortified product, value chain
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronutrient-fortified yoghurtDietary supplement
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.
BCCBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Micronutrient-fortified yoghurt | Experimental | Micronutrient-fortified yoghurt + BCC
All eligible children within the intervention arm will receive one fortified yoghurt per day, every day of the week, if the household satisfied to the contract of reliability in milk supply during the previous week, during the one year duration of the intervention. Receives: Dietary Supplement: Micronutrient-fortified yoghurt; Behavioral: BCC |
| Control | Active comparator | BCC
Children will not receive fortified yoghurt during the duration of the intervention Receives: Behavioral: BCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agnes LePort
- Sponsor type
- University, hospital or other
- Collaborators
- GRET, Cellule de Lutte contre la Malnutrition, Universite Gaston Berger
- Responsible party
- Sponsor-investigator, Agnes LePort, International Food Policy Research Institute
- Investigators
- Rahul Rawat, PhD, Principal investigator, IFPRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079961
- Sponsor's protocol ID
- EC CRP4 Senegal
- Status last verified
- Mar 2014
- First submitted
- 21 May 2013
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Port A, Bernard T, Hidrobo M, Birba O, Rawat R, Ruel MT. Delivery of iron-fortified yoghurt, through a dairy value chain program, increases hemoglobin concentration among children 24 to 59 months old in Northern Senegal: A cluster-randomized control trial. PLoS One. 2017 Feb 28;12(2):e0172198. doi: 10.1371/journal.pone.0172198. eCollection 2017.
PubMed 28245227
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Nutrition Through Agricultural Contracts; Better Contracts Through Nutrition Incentives: A Case Study of Utilizing a Dairy Value Chain in Northern Senegal to Reduce Anemia and Improve Milk Supply
- ClinicalTrials.gov ID
- NCT02079961
- Acronym / sponsor ID
- EC CRP4 Senegal
- Conditions
- Anemia, Iron-Deficiency
- Keywords
- anemia, children, iron-fortified product, value chain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Agnes LePortUniversity, hospital or other
- Collaborators
- GRET, Cellule de Lutte contre la Malnutrition, Universite Gaston Berger
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
- 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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micronutrient-fortified yoghurt | Experimental | Dietary Supplement: Micronutrient-fortified yoghurt, Behavioral: BCCMicronutrient-fortified yoghurt + BCC All eligible children within the intervention arm will receive one fortified yoghurt per day, every day of the week, if the household satisfied to the contract of reliability in milk supply during the previous week, during the one year duration of the intervention. |
| Control | Active comparator | Behavioral: BCCBCC Children will not receive fortified yoghurt during the duration of the intervention |
Who may qualify
- Ages
- 24 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Household with no children between 24 to 59 months old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronutrient-fortified yoghurtA 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. | Dietary supplement | Micronutrient-fortified yoghurt |
| BCCBehavior 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. | Behavioural | Control, Micronutrient-fortified yoghurt |
Primary outcome
Prevalence of anemia in children 24-59 months after receiving iron fortified yoghurt during a one year intervention
Time frame: one year
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.
1 secondary outcome
Frequency of milk supply by pastoralist during one year intervention
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Derived from this study: PubMed 28245227Le Port A, Bernard T, Hidrobo M, Birba O, Rawat R, Ruel MT. Delivery of iron-fortified yoghurt, through a dairy value chain program, increases hemoglobin concentration among children 24 to 59 months old in Northern Senegal: A cluster-randomized control trial. PLoS One. 2017 Feb 28;12(2):e0172198. doi: 10.1371/journal.pone.0172198. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Rawat, PhD principal investigator
IFPRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Micronutrient-fortified yoghurt and BCC in people with Anemia and Iron-Deficiency, run by Agnes LePort at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anemia in children 24-59 months after receiving iron fortified yoghurt during a one year intervention (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02079961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2014.