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Nutrient Intake DisorderNCT02376140

Food Consumption and Iron Status Survey in Two Provinces of Rural Burkina Faso

An observational study of Nutrient Intake Disorder and Deficiency of Micronutrients, run by Institut de Recherche pour le Developpement.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 36 to 59 monthsHealthy volunteers can take part
How many people
480 participants
Where
No sites listed yet
Study dates
Jun 2010to Feb 2012
Phase
Observational
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 36 to 59 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children 36-59 months old and their mothers

Who may be able to join

  • 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

Who cannot join

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

About this study

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.

Read the detailed description

Objectives of the study

The main objectives of the study were:

  • To determine iron, zinc, polyphenolic compounds, and phytate content in raw sorghum grains and cooked sorghum based dishes;
  • To estimate the prevalence and level of sorghum consumption in women and preschool children;
  • To determine the percent contribution of Sorghum to total vitamin A, iron and zinc intake;
  • To assess the prevalence of inadequate intakes of vitamin A, iron and zinc as defined by the cut-point method using Estimated Average Requirements for women and children according to sex and age;
  • To determine the prevalence of micronutrient deficiencies using international (WHO) cut-offs for serum retinol, serum ferritin and serum zinc.

Two secondary methodological objectives were added because of their scientific interest and of their potential practical implications:

  • To assess the performance of dietary diversity scores in reflecting adequacy of micronutrient intakes;
  • To assess the performance of questionnaires on expenditures at the household level in estimating food consumption of household members.

Setting

The study has been conducted in the "Boucle du Mouhoun" and "Centre-Ouest" regions located in Western Burkina Faso. These regions were selected based on a combination of health, agriculture, living conditions and demographics criteria, which included data on sorghum production, household consumption and prevalence of malnutrition.

The province of Sourou in the "Boucle du Mouhoun" region and the province of Sanguié in the "Centre-Ouest" region were chosen purposely based notably on available information on sorghum production or consumption and on some of the principal investigators general knowledge of the field.

Study design

It was a cross-sectional survey in two rounds: a first round during the lean period (July-August 2010) characterized by very low food availability in Burkina Faso; and a second round during the period of greatest food availability, immediately after harvest (November 2010-January 2011). To enhance the study power, the same individuals were surveyed during these two rounds.

The study had two main components: the "food consumption" component and "lab analysis" component.

The food consumption component included:

  • A quantitative 24 hour recall of dietary intake on a random sample of preschool children aged 3-5 y and their mothers
  • A qualitative dietary diversity questionnaire for both the children and the mothers, administered on the same day as the 24-h recall but by a different enumerator
  • A repetition of the 24 hour recall on non consecutive days using a randomly selected subsample of approximately one third of the original sample
  • A questionnaire about income and expenditure on a subsample of approximately one other third of the households (i.e. not the households having a repetition of the 24-h recall)
  • Anthropometric data (weight, height and MUAC) collected for all children and their mothers
  • A socio demographic questionnaire and morbidity recall for all children and their mothers

The laboratory component included:

  • Collection of blood samples from a randomly selected subsample of mothers and children (one third of the original sample) for vitamin A, iron and zinc biochemical indicators as well as haemoglobin and acute phase proteins (C-reactive protein and alpha-1-glycoprotein as markers of inflammation); this blood sampling took place only during the second round of the survey (November 2010 - January 2011).
  • Collection of raw sorghum and cooked sorghum dishes samples for determination of iron, zinc, polyphenolic compounds and phytate content; food sample collection took place during the two rounds.

Target population

Women and preschool children were selected because their micronutrient requirements are highest due to their needs for reproduction and growth, respectively. The age range for targeted preschool children was 36-59 months for several reasons: Firstly, we wanted to be sure to exclude breastfed children since the measure of breast milk intakes are very complicated to implement on the field; Secondly, starting at the age of 36 months, most children are used to eating from the common family dish and this made the recall easier, while keeping the number of individual recipes lower. Thirdly, venous puncture was less problematic for children aged 36 months or more.

Sample size for dietary intake: using food consumption data from a survey conducted among women of reproductive age in Ouagadougou, one determined that for a reasonable hypothesis of a coefficient of variation of sorghum intakes of 0.60, with a precision of 0.10, a type I error of 0.05 and supposing a design effect of 1.5, the required sample size was 207 subjects. Finally we decided to set the sample size at 240 households per province and per round, to account for lost of follow-up. The repetition of 24 hour recalls was perfomed on 3 out of 8 subjects.

Sample size for the biochemical indicators: Given a type I error of 0.05, we calculated hypothetical sample sizes for different values of the prevalence of micronutrient deficiencies (30, 40 or 50%) and different desired precisions (either 0.05, 0.075, 0.10, 0.125 or 0.15) and also taking into account different hypotheses about the survey design effect. A huge sample size would have been required to get a precision less than 0.10, depending on the design effect, if data had to be representative at the individual level (women and children) in each province. According to constraints in logistics and financing, we decided to limit the sample size to 90 women and 90 children in each province.

Sample size for sorghum analysis: Five samples of each type of sorghum (red, white, hybrid) and 5 samples of each type of sorghum-based food (paste, gruel) were analysed for each province at each round. This adds up to 30 samples of each class of sorghum and of sorghum-based food in each province at each round, then a total of 120 food samples. However, given the potentially high variability of nutrient density in some food samples, each analysis was performed on a pool of 6 samples of the same type, coming from close villages belonging to a common health area.

Location and sampling procedure

In each province, a multistage sampling procedure was used:

  • Firstly a list of all health centres in each province was made and the population size for corresponding health areas was obtained from heath districts and/or administrative data. Five centres were randomly selected in each province, with a probability proportional to size (of population in health areas).
  • The same proportional to size sampling technique was used to select 6 villages in each health area, leading to a total of 30 villages.
  • Finally, 8 households were selected in each village, from the list of eligible households which was obtained by a census performed by enumerators a few days ahead of the data collection.
  • Among the 8 HH included a further random selection was made to determine which of them took part in the repetition of 24-h recall (3 HH) and in blood sampling (3 HH).

Data Collection

Anthropometric data were collected for all study participants (mothers and children) using standard WHO procedures Food intake was assessed by 24-H recall using the multiple pass method. A set of standard recipes was prepared (by observation) and other individual recipes were investigated directly. A local Food Composition table was built by compliling information from available food composition tables (from Mali, FAO, USDA).

The food sampling was done in households selected for this purpose in each village. In these households, about 1 kg of sorghum (white or red) was sampled in clean new polyethylene plastic bags to avoid any contamination. For meals sampling, the selected households were asked to prepare a sorghum based dish (tô or porridge) according to their habits. All samples were put into icebox for transportation to the IRSS laboratory where extraction and analyses was done.

The blood collection was conducted at health centres in cool places with subdued light and conducted by a trained health professional. Care was taken to avoid any contact between the samples and surrounding dust, sweat, or other possible exogenous sources of contamination. The sampling technique was a venous puncture of 10 mL of blood.

Keywords
micronutrient deficiency, 24-H recall, West Africa, Food consumption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02376140
Study groupRoleWhat they receive
WomenMothers of children 36-59 months old No intervention
ChildrenChildren 36-59 months old No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    quantitative 24-H recalls + repetition on a subsample

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

Secondary outcomes (2)
  1. Micronutrient status (Biomarkers of vitamin A, iron and zinc + inflammation proteins)

    Blood sampling and ELISA analysis

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

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

    Contents of foods in iron, zinc, polyphenolic compounds and phytates

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2015 (estimated)
  2. Study startJun 2010
  3. Primary completionNov 2011
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02376140
Sponsor's protocol ID
HarvestPlus Agreement #8908
Status last verified
Feb 2015
First submitted
21 Feb 2015
Last updated
3 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26101623

Questions about this trial

What is this clinical trial studying?

An observational study of Nutrient Intake Disorder and Deficiency of Micronutrients, run by Institut de Recherche pour le Developpement.

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 3 inclusion and 3 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 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

Usual dietary intakes (quantitative 24-H recalls + repetition on a subsample) (time frame: Up to 2 months data collection repeated 4 months apart (July-August 2010 / November-December 2010)). 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 NCT02376140, 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 3 Mar 2015.

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