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.
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
- Conditions the study is for
- Nutrient Intake Disorder, Deficiency of Micronutrients
- 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 group | Role | What they receive |
|---|---|---|
| Women | Mothers of children 36-59 months old No intervention | |
| Children | Children 36-59 months old No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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.
- First posted3 Mar 2015 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionFeb 2012
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 Nutrient Intake DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, HarvestPlus
- Responsible party
- Principal investigator, Yves MARTIN-PREVEL, MD, PhD, Institut de Recherche pour le Developpement
- Investigators
- Yves MARTIN-PREVEL, PhD, Principal investigator, Institute of Research fo Development (IRD)
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Consumption and Iron Status Survey in Two Provinces of Rural Burkina Faso
- ClinicalTrials.gov ID
- NCT02376140
- Acronym / sponsor ID
- HarvestPlus Agreement #8908
- Keywords
- micronutrient deficiency, 24-H recall, West Africa, Food consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, HarvestPlus
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Mar 2015 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women | – | –Mothers of children 36-59 months old No intervention |
| Children | – | –Children 36-59 months old No intervention |
Who may qualify
- Ages
- 36 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 36-59 months old and their mothers
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- refusal
- plan to leave the village
- visible severe unhealthy condition or handicap
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
quantitative 24-H recalls + repetition on a subsample
2 secondary outcomes
Micronutrient status (Biomarkers of vitamin A, iron and zinc + inflammation proteins)
Time frame: Up to 2 months data collection (November-December 2010)
Food composition (Contents of foods in iron, zinc, polyphenolic compounds and phytates)
Time frame: Up to 2 months data collection repeated 4 months apart (July-August 2010 / November-December 2010)
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 3 Mar 2015.
- Results publication: PubMed 26101623Arsenault 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.
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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.
Yves MARTIN-PREVEL, PhD principal investigator
Institute of Research fo Development (IRD)
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.