NCT02079961

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

1.1 years

First QC Date

May 21, 2013

Last Update Submit

March 5, 2014

Conditions

AnemiaIron-Deficiency

Keywords

anemiachildreniron-fortified productvalue chain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Frequency of milk supply by pastoralist during one year intervention

    one year

Study Arms (2)

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.

Dietary Supplement: Micronutrient-fortified yoghurtBehavioral: BCC

Control

ACTIVE COMPARATOR

BCC Children will not receive fortified yoghurt during the duration of the intervention

Behavioral: BCC

Interventions

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.

Micronutrient-fortified yoghurt
BCCBEHAVIORAL

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.

ControlMicronutrient-fortified yoghurt

Eligibility Criteria

Age24 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Household with no children between 24 to 59 months old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IFPRI

Dakar, Senegal

Location

Related Publications (1)

  • 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.

    PMID: 28245227DERIVED

MeSH Terms

Conditions

AnemiaAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesAnemia, HypochromicIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rahul Rawat, PhD

    IFPRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoctoral Research Fellow

Study Record Dates

First Submitted

May 21, 2013

First Posted

March 6, 2014

Study Start

January 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

SE(1)