An observational study in Iron Deficiency, Vitamin A Deficiency and Vitamin B 12 Deficiency, sponsored by University of California, Davis. Completed at 1 site in Ghana. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-18.
Sponsored by University of California, Davis · Observational
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.
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:
386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.
This study's enrollment of 995 is above the median of 200 across 77 observational studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
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Households in the urban and rural areas in Tolon and Kumbungu districts, in northern Ghana
Pilot survey
Inclusion Criteria:
Exclusion Criteria:
RID Pilot 1
Inclusion Criteria:
Exclusion Criteria:
RID Pilot 2
Inclusion Criteria:
Exclusion Criteria:
Formative Research
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Survey of non-pregnant, non-lactating women 15-49 years of age (n=250)
Other: N/A (observational study)
Survey of lactating women 15-49 years of age who are currently breastfeeding a child 4-18 months of age (n=250)
Other: N/A (observational study)
Survey of children 2-5 years of age (n=250)
Other: N/A (observational study)
Two-week study to assess total body vitamin A stores in a sample of non-pregnant, non-lactating women 15-49 years of age (n=30)
Other: N/A (observational study)
Kinetic study with "Super-woman" design to develop a prediction equation to assess total body vitamin A stores among non-pregnant, non-lactating women 15-49 years of age (n=123)
Other: N/A (observational study)
Focus group discussions conducted among women of reproductive age, older women, and men (n=120 total)
Other: N/A (observational study)
Survey of retail outlets selling fortified staple foods and/or bouillon (n=50 shop owners or operators)
Other: N/A (observational study)
Observations of cooking of local dishes by selected participants (n=50) enrolled in the pilot survey.
Other: N/A (observational study)
N/A (observational study)
Hemoglobin
Hemoglobin concentration in venous blood (g/dL) among women and children
Time frame: Day 1
Iron status
Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children
Time frame: Day 1
Vitamin A status
Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children
Time frame: Day 1
Vitamin B12 status
Concentrations of vitamin B12 in serum among women and children
Time frame: Day 1
Folate status
Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)
Time frame: Day 1
Zinc status
Serum zinc concentration among women and children
Time frame: Day 1
Breast milk vitamin A concentration
Vitamin A concentration in breast milk, expressed per unit volume and per gram fat
Time frame: Day 1
Breast milk vitamin B12 concentration
Vitamin B12 concentration in breast milk
Time frame: Day 1
Total body vitamin A stores
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 7
Total body vitamin A stores
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
Coefficient "Fa"
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
Coefficient "S"
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: Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
Prevalence of anemia and micronutrient deficiencies
Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs
Time frame: Day 1
Urinary iodine concentration
Iodine concentration of urine among women and children
Time frame: Day 1
Themes from focus group discussions
Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues
Time frame: Day 1
Recipe ingredients
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
Fortified food accessibility
Availability, price, and fortification levels of fortified food products in markets
Time frame: Day 1
Blood pressure
Blood pressure measured among women and children (mm Hg, systolic and diastolic)
Time frame: Day 1
Hypertension
Prevalence of blood pressure measurements above cutoffs for hypertension
Time frame: Day 1
Height, cm
Standing height measured among women and children
Time frame: Day 1
Weight, kg
Weight measurement among women and children
Time frame: Day 1
Waist to hip ratio
Waist and hip circumference (measured in cm) among women and their ratio
Time frame: Day 1
Mid-upper arm circumference, cm
Mid-upper arm circumference measured among children
Time frame: Day 1
Anthropometric Z-scores
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 undernutrition
Prevalence of anthropometric Z-scores or mid-upper arm circumference below WHO cutoffs to indicate child undernutrition
Time frame: Day 1
Prevalence of overweight and obesity
Prevalence of body mass index (women) or BMI-for-age Z-score (children) above WHO cutoffs
Time frame: Day 1
Morbidity symptoms
Reported malaria, diarrhea, fever, or vomiting in the past 7 days (all survey participants)
Time frame: Day 1
Inflammation
Serum concentrations of CRP, AGP, amyloid A, MCP-1, IL-6, IL-10, IL-1b, adiponectin
Time frame: Day 1
Household-food consumption
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
Individual dietary intake
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
Urinary sodium concentration
Expressed per unit volume and in relation to urinary creatinine concentration
Time frame: Day 1
Status of other micronutrients
Concentrations of micronutrients in serum and breast milk (vitamins E, B1, B2, B3, B5, B6, B7)
Time frame: Day 1
Micronutrient supplement use
Reported use of daily or periodic micronutrient supplements in the past month
Time frame: Day 1
Consumption of fruits and vegetables
Assessed using the WHO STEPS questionnaire
Time frame: Day 1
Consumption of snacks and sweetened beverages
Assessed using the WHO STEPS questionnaire
Time frame: Day 1
Physical activity
Assessed using the WHO STEPS questionnaire
Time frame: Day 1
Tobacco use
Assessed using the WHO STEPS questionnaire
Time frame: Day 1
Alcohol use
Assessed using the WHO STEPS questionnaire
Time frame: Day 1
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Feb 2022, 16 months.
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