NCT02376140

Brief Summary

Sorghum is the primary source of food for more than 300 million people in arid and semi-arid regions of Africa. The grain is one of the few crops that grow well in arid climates, but has a low content in most essential nutrients and is difficult to digest. The African Bio-fortified Sorghum (ABS) Project, a consortium of nine institutions led by Africa Harvest Biotech Foundation International, is working to develop new varieties of sorghum that are easier to digest and contain lower levels of phytates to improve the bioavailability of micronutrients. In order to determine their target levels, the ABS project needs reliable information on current levels of micronutrient deficiency and consumption patterns of sorghum and nutrients of interest, e.g. iron, zinc, and vitamin A in women and preschool children, which are not currently available in Burkina Faso. A background nutrition survey among children and women, comprised of two rounds, one in the lean season (July - August) and one in the harvest season (November - January), has been conducted to provide quantitative estimates of sorghum, vitamin A, iron and zinc intakes by women and young children from two rural provinces of Burkina Faso. The survey also had a biochemical component which included blood collection and analysis for indicators of deficiency for vitamin A, iron and zinc. Other important components of this study included anthropometric measurements, household and child morbidity questionnaires, and collection of sorghum samples for analysis of phytate, vitamin A, iron and zinc content.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

1.4 years

First QC Date

February 21, 2015

Last Update Submit

February 25, 2015

Conditions

Keywords

micronutrient deficiency24-H recallWest AfricaFood consumption

Outcome Measures

Primary Outcomes (1)

  • Usual dietary intakes (quantitative 24-H recalls + repetition on a subsample)

    quantitative 24-H recalls + repetition on a subsample

    Up to 2 months data collection repeated 4 months apart (July-August 2010 / November-December 2010)

Secondary Outcomes (2)

  • Micronutrient status (Biomarkers of vitamin A, iron and zinc + inflammation proteins)

    Up to 2 months data collection (November-December 2010)

  • Food composition (Contents of foods in iron, zinc, polyphenolic compounds and phytates)

    Up to 2 months data collection repeated 4 months apart (July-August 2010 / November-December 2010)

Study Arms (2)

Women

Mothers of children 36-59 months old No intervention

Children

Children 36-59 months old No intervention

Eligibility Criteria

Age36 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children 36-59 months old and their mothers

You may qualify if:

  • to have a child aged 36-59 months with a mother living in the same HH;
  • to give informed consent;
  • not to plan to leave the village before the next round of data collection

You may not qualify if:

  • refusal
  • plan to leave the village
  • visible severe unhealthy condition or handicap

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Arsenault JE, Nikiema L, Allemand P, Ayassou KA, Lanou H, Moursi M, De Moura FF, Martin-Prevel Y. Seasonal differences in food and nutrient intakes among young children and their mothers in rural Burkina Faso. J Nutr Sci. 2014 Nov 13;3:e55. doi: 10.1017/jns.2014.53. eCollection 2014.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

  • Yves MARTIN-PREVEL, PhD

    Institute of Research fo Development (IRD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

February 21, 2015

First Posted

March 3, 2015

Study Start

June 1, 2010

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

March 3, 2015

Record last verified: 2015-02