NCT01724073

Brief Summary

A food-to-food fortification strategy has been designed based on traditional foods of Burkina Faso to fight against micronutrient deficiencies in young children. Leafy vegetable sauces were formulated to improve their micronutrient contents and bioavailability. This efficacy study was designed to assess the effects of the regular consumption (one meal per day, 6 days per week) of these leafy-vegetable sauces enriched or not with liver on iron, zinc and vitamin A status, growth and morbidity of young children from poor urban districts of Ouagadougou. The study is conducted by IRD and IRSAT-DTA and will last 6 months. 432 12-15 month-old children will be recruited and randomly assigned to one of the four following arms: three intervention groups, the two first receiving leafy vegetable sauce, the third one receiving one meal made of the fortified Misola gruel. In these three arms, blood samples will be collected at the beginning and at the end of the study. The fourth arm is an external control group and will not receive any food. In this fourth arm, blood samples will be collected only at the end of the study. Biochemical indicators of micronutrient status will be determined, and anthropometric data will be collected in all children. Morbidity will also be assessed in children of intervention groups.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

October 25, 2012

Last Update Submit

March 4, 2014

Conditions

Anemia

Keywords

food to food fortification strategyleafy vegetableironzincvitamin Agrowth

Outcome Measures

Primary Outcomes (2)

  • Change in micronutrient status

    iron, zinc and vitamin A status using plasma concentrations

    six months

  • Growth

    Weight, length, mid-upper arm circumference

    6 months

Secondary Outcomes (3)

  • food consumption

    at t=around 1 month

  • Intake of experimental food

    up to 6 months

  • Morbidity

    up to 6 months

Study Arms (4)

Leafy vegetable-fish sauce

EXPERIMENTAL

one meal per day, 6 days a week, with leafy vegetable-fish sauce + tô, a local cereal-based paste

Dietary Supplement: Leafy vegetable-fish sauce

Leafy vegetable-fish/liver sauce

EXPERIMENTAL

one meal per day, 6 days a week, 5 days with leafy vegetable-fish sauce + tô, 1 day with leafy vegetable-liver sauce + tô

Dietary Supplement: Leafy vegetable-fish/liver sauce

Misola

EXPERIMENTAL

one meal per day, 6 days a week, with gruel prepared with the fortified Misola flour

Dietary Supplement: Misola

no test food

NO INTERVENTION

control group receiving no test food

Interventions

Leafy vegetable-fish sauceDIETARY_SUPPLEMENT
Leafy vegetable-fish sauce
Leafy vegetable-fish/liver sauceDIETARY_SUPPLEMENT
Leafy vegetable-fish/liver sauce
MisolaDIETARY_SUPPLEMENT
Misola

Eligibility Criteria

Age12 Months - 15 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age between 12 and 15 months
  • signed informed consent by parent or caregiver
  • accept to eat every ingredient used for the preparation of the sauces

You may not qualify if:

  • any chronic illness affecting growth or iron status (thalassemia or sickle-cell anemia) no informed consent
  • severe acute malnutrition which will require direct treatment
  • severe anemia which will require direct treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche en Sciences Aplliquées et Technologie - DTA

Ouagadougou, Centre Region, Burkina Faso

Location

Related Links

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Claire Mouquet-Rivier, PhD

    Institut de Recherche pour le Developpement

    PRINCIPAL INVESTIGATOR

  • Bréhima Diawara, PhD

    Institut de Recherche en Sciences Aplliquées et Technologie - DTA

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 25, 2012

First Posted

November 9, 2012

Study Start

December 1, 2012

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

BU(1)