University of Ghana
Accra, Ghana
NCT Number: NCT04632771
This pilot aims to generate data that are critical for informing the design of a planned, more detailed study to evaluate the effect of multiple micronutrient (MN)-fortified bouillon cube on biomarkers of nutrient status of women and children. Data collection includes measures of nutritional status and dietary intake among women and children and their households in communities in northern Ghana.
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Notify Me2 year and older
All sexes
Observational
Accra, Ghana
Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa including Ghana, which contributes to impaired growth and development in children, increased risk of mortality, and low economic productivity in adults. While large-scale intervention programs (including salt iodization and cooking oil and wheat flour fortification) exist, these programs are often not well-monitored, and they often provide only a subset of nutrients or reach only a subset of the deficient population.
Bouillon cubes may be an ideal fortification vehicle for delivering micronutrients in West Africa because they are purchased by most households (including rural and poorer households), added to home-made meals and consumed by most members of the household in relatively constant amounts, and they are mainly processed centrally at large scale. However, several important questions must be addressed regarding the extent to which multi-fortified bouillon cubes can address inadequate intake of key micronutrients.
Objective: This pilot aims to generate data that are critical for informing the design of a planned, more detailed study to evaluate the effect of multiple micronutrient-fortified bouillon cube on biomarkers of nutrient status of women and children.
Methods: This will be a cross-sectional study, which will be conducted in the Kumbungu and Tolon districts in the Northern Region, where a recent survey showed that micronutrient deficiencies were common. Four sets of research activities will be carried out, including:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Pilot survey
Inclusion criteria
Exclusion criteria
RID Pilot 1
Inclusion criteria
Exclusion criteria
RID Pilot 2
Inclusion criteria
Exclusion criteria
Formative Research
Inclusion criteria
N/A (observational study)
Time frame: Day 1
Hemoglobin concentration in venous blood (g/dL) among women and children
Time frame: Day 1
Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children
Time frame: Day 1
Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children
Time frame: Day 1
Concentrations of vitamin B12 in serum among women and children
Time frame: Day 1
Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)
Time frame: Day 1
Serum zinc concentration among women and children
Time frame: Day 1
Vitamin A concentration in breast milk, expressed per unit volume and per gram fat
Time frame: Day 1
Vitamin B12 concentration in breast milk
Time frame: Day 7
Distribution of total body vitamin A stores among non-pregnant, non-lactating women, expressed as total mass and per gram of liver, estimated by retinol isotope dilution
Time frame: Day 14
Distribution of total body vitamin A stores among non-pregnant, non-lactating women, expressed as total mass and per gram of liver, estimated by retinol isotope dilution
Time frame: Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
Defined as the fraction of the oral tracer dose absorbed and retained in stores, estimated by modeling of data on labeled and unlabelled vitamin A in plasma collected using a "Super Woman" design and used to calculate total body stores for individual participants.
Time frame: Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
Defined as retinol specific activity in plasma/stores at time "t", estimated by modeling of data on labeled and unlabelled vitamin A in plasma collected using a "Super Woman" design and used to calculate total body stores for individual participants.
Time frame: Day 1
Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs
Time frame: Day 1
Iodine concentration of urine among women and children
Time frame: Day 1
Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues
Time frame: Day 1
Quantity of each recipe ingredient (including bouillon and salt) used in common local recipes; interpreted in relation to cooking duration and temperature (type and duration, e.g. of boiling) used in common recipes
Time frame: Day 1
Availability, price, and fortification levels of fortified food products in markets
Time frame: Day 1
Blood pressure measured among women and children (mm Hg, systolic and diastolic)
Time frame: Day 1
Prevalence of blood pressure measurements above cutoffs for hypertension
Time frame: Day 1
Standing height measured among women and children
Time frame: Day 1
Weight measurement among women and children
Time frame: Day 1
Waist and hip circumference (measured in cm) among women and their ratio
Time frame: Day 1
Mid-upper arm circumference measured among children
Time frame: Day 1
Z-scores calculated for young children based on WHO growth standards (height-for-age, weight-for-height, height-for-age, BMI-for-age)
Time frame: Day 1
Prevalence of anthropometric Z-scores or mid-upper arm circumference below WHO cutoffs to indicate child undernutrition
Time frame: Day 1
Prevalence of body mass index (women) or BMI-for-age Z-score (children) above WHO cutoffs
Time frame: Day 1
Reported malaria, diarrhea, fever, or vomiting in the past 7 days (all survey participants)
Time frame: Day 1
Serum concentrations of CRP, AGP, amyloid A, MCP-1, IL-6, IL-10, IL-1b, adiponectin
Time frame: Day 1
Calculated daily household level consumption and individual apparent consumption of fortified foods (wheat flour, oil, salt) and bouillon estimated using 1-month recall
Time frame: Day 1
Dietary intake of fortified foods and bouillon, measured by 24h recall among a subset of women participating in the survey who also participate in cooking observations
Time frame: Day 1
Expressed per unit volume and in relation to urinary creatinine concentration
Time frame: Day 1
Concentrations of micronutrients in serum and breast milk (vitamins E, B1, B2, B3, B5, B6, B7)
Time frame: Day 1
Reported use of daily or periodic micronutrient supplements in the past month
Time frame: Day 1
Assessed using the WHO STEPS questionnaire
Time frame: Day 1
Assessed using the WHO STEPS questionnaire
Time frame: Day 1
Assessed using the WHO STEPS questionnaire
Time frame: Day 1
Assessed using the WHO STEPS questionnaire
Time frame: Day 1
Assessed using the WHO STEPS questionnaire
University of California, Davis
Other
A Pilot Study to Evaluate the Nutritional Status of Women and Children in Northern Ghana, and Knowledge, Attitudes and Practices Related to Bouillon Cube Use
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