- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04632771
Nutritional Status and Bouillon Use in Northern Ghana
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Pilot survey: The investigators will recruit non-pregnant, non-lactating women of reproductive age, WRA (n = 250), children 2-5 years of age (n = 250), and lactating women (n= 250) who will be identified from households in selected communities using the random walk method. Information collected will include anthropometric and micronutrient status, hemoglobin concentration, inflammation, morbidity, household-level food consumption, and individual dietary intakes.
- Retinol isotope dilution (RID) Pilot Study 1: The investigators will recruit non-pregnant and nonlactating women of reproductive age, WRA (n = 30) from a subset of the same communities as the pilot survey using the random walk method, and quantitatively estimate their total body vitamin A stores after consuming a dose of d6-labelled vitamin A. Total body stores of vitamin A will be estimated at 14 days after dosing.
- Retinol isotope dilution (RID) Pilot Study 2 (kinetic study): Based on results from RID pilot study 1, the investigators will recruit non-pregnant and non-lactating women of reproductive age, WRA (n = 123) from a subset of the same communities as the pilot survey using the random walk method, to construct a population-level plasma retinol kinetic curve, after consuming a dose of d6-labelled vitamin A. A compartmental model will be fit to the plasma retinol kinetic data to develop population-specific coefficients for the RID prediction equation to quantitatively estimate total body vitamin A stores of WRA in the study population.
- Formative research: The investigators will (a) conduct focus group discussions on knowledge, attitudes and practices related to salt and bouillon cube use, nutrition and health problems in the community, and micronutrient fortification; (b) perform a market assessment of the availability and cost of fortified, non-fortified and potentially fortifiable foods in the communities; and (c) observe how various local food recipes are prepared, including the types and quantities of ingredients used, and cooking duration and temperature.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Accra, Ghana
- University of Ghana
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Pilot survey
Inclusion Criteria:
- non-pregnant, non-lactating woman of reproductive age (15-49 years) OR child 2-5 years of age OR non-pregnant lactating woman (4-18 mo post-partum, 15-49 years of age)
- signed informed consent by participant (if adult woman) or by at least one parent or guardian (if child)
Exclusion Criteria:
- severe illness warranting hospital referral
- chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially inferring with nutritional status
- unable to provide informed consent due to impaired decision making abilities (if adult woman, or caretaker of potentially eligible child)
- current participation in a clinical trial
RID Pilot 1
Inclusion Criteria:
- non-pregnant, nonlactating woman of reproductive age (15-49 years)
- signed informed consent
- planning to remain in the study area for the next 1 month
- not planning to become pregnant during the next 1 month
Exclusion Criteria:
- unable to provide informed consent due to impaired decision making abilities
- pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin)
- severe illness warranting hospital referral
- reported fever, vomiting or diarrhea (> 3 liquid or semi-liquid stools in 24h) in 7 d prior to data collection
- chronic medical condition (e.g. malignancy, gastrointestinal disease) or congenital anomalies requiring frequent medical attention or potentially inferring with nutritional status
- current participation in a clinical trial
- hemoglobin concentration <80 g/L on the day of isotope dosing
- C-reactive protein concentration > 5 mg/L on the day of isotope dosing
- reported use of micronutrient supplements that contain vitamin A more than 1 time/wk in the past 30 days
RID Pilot 2
Inclusion Criteria:
- non-pregnant, nonlactating woman of reproductive age (15-49 years)
- signed informed consent
- planning to remain in the study area for the next 4 months
- not planning to become pregnant during the next 4 months
Exclusion Criteria:
- unable to provide informed consent due to impaired decision making abilities
- pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin)
- severe illness warranting hospital referral
- reported fever, vomiting or diarrhea (> 3 liquid or semi-liquid stools in 24h) in 7 d prior to data collection
- chronic medical condition (e.g. malignancy, gastrointestinal disease) or congenital anomalies requiring frequent medical attention or potentially inferring with nutritional status
- current participation in a clinical trial
- hemoglobin concentration <80 g/L on the day of isotope dosing
- C-reactive protein concentration > 5 mg/L on the day of isotope dosing
- reported use of micronutrient supplements that contain vitamin A more than 1 time/wk in the past 30 days
Formative Research
Inclusion Criteria:
- Adults (including women, men, and other key community members such as merchants, etc.)
- Provision of written informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pilot survey: non-pregnant, non-lactating women
Survey of non-pregnant, non-lactating women 15-49 years of age (n=250)
|
N/A (observational study)
|
Pilot survey: lactating women
Survey of lactating women 15-49 years of age who are currently breastfeeding a child 4-18 months of age (n=250)
|
N/A (observational study)
|
Pilot survey: children
Survey of children 2-5 years of age (n=250)
|
N/A (observational study)
|
RID Pilot 1
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)
|
N/A (observational study)
|
RID Pilot 2
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)
|
N/A (observational study)
|
Focus group discussions
Focus group discussions conducted among women of reproductive age, older women, and men (n=120 total)
|
N/A (observational study)
|
Market assessment
Survey of retail outlets selling fortified staple foods and/or bouillon (n=50 shop owners or operators)
|
N/A (observational study)
|
Recipe observations
Observations of cooking of local dishes by selected participants (n=50) enrolled in the pilot survey.
|
N/A (observational study)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin
Time Frame: Day 1
|
Hemoglobin concentration in venous blood (g/dL) among women and children
|
Day 1
|
Iron status
Time Frame: Day 1
|
Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children
|
Day 1
|
Vitamin A status
Time Frame: Day 1
|
Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children
|
Day 1
|
Vitamin B12 status
Time Frame: Day 1
|
Concentrations of vitamin B12 in serum among women and children
|
Day 1
|
Folate status
Time Frame: Day 1
|
Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)
|
Day 1
|
Zinc status
Time Frame: Day 1
|
Serum zinc concentration among women and children
|
Day 1
|
Breast milk vitamin A concentration
Time Frame: Day 1
|
Vitamin A concentration in breast milk, expressed per unit volume and per gram fat
|
Day 1
|
Breast milk vitamin B12 concentration
Time Frame: Day 1
|
Vitamin B12 concentration in breast milk
|
Day 1
|
Total body vitamin A stores
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
|
Day 7
|
Total body vitamin A stores
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
|
Day 14
|
Coefficient "Fa"
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.
|
Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
|
Coefficient "S"
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.
|
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
Time Frame: Day 1
|
Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs
|
Day 1
|
Urinary iodine concentration
Time Frame: Day 1
|
Iodine concentration of urine among women and children
|
Day 1
|
Themes from focus group discussions
Time Frame: Day 1
|
Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues
|
Day 1
|
Recipe ingredients
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
|
Day 1
|
Fortified food accessibility
Time Frame: Day 1
|
Availability, price, and fortification levels of fortified food products in markets
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Day 1
|
Blood pressure measured among women and children (mm Hg, systolic and diastolic)
|
Day 1
|
Hypertension
Time Frame: Day 1
|
Prevalence of blood pressure measurements above cutoffs for hypertension
|
Day 1
|
Height, cm
Time Frame: Day 1
|
Standing height measured among women and children
|
Day 1
|
Weight, kg
Time Frame: Day 1
|
Weight measurement among women and children
|
Day 1
|
Waist to hip ratio
Time Frame: Day 1
|
Waist and hip circumference (measured in cm) among women and their ratio
|
Day 1
|
Mid-upper arm circumference, cm
Time Frame: Day 1
|
Mid-upper arm circumference measured among children
|
Day 1
|
Anthropometric Z-scores
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)
|
Day 1
|
Prevalence of undernutrition
Time Frame: Day 1
|
Prevalence of anthropometric Z-scores or mid-upper arm circumference below WHO cutoffs to indicate child undernutrition
|
Day 1
|
Prevalence of overweight and obesity
Time Frame: Day 1
|
Prevalence of body mass index (women) or BMI-for-age Z-score (children) above WHO cutoffs
|
Day 1
|
Morbidity symptoms
Time Frame: Day 1
|
Reported malaria, diarrhea, fever, or vomiting in the past 7 days (all survey participants)
|
Day 1
|
Inflammation
Time Frame: Day 1
|
Serum concentrations of CRP, AGP, amyloid A, MCP-1, IL-6, IL-10, IL-1b, adiponectin
|
Day 1
|
Household-food consumption
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
|
Day 1
|
Individual dietary intake
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
|
Day 1
|
Urinary sodium concentration
Time Frame: Day 1
|
Expressed per unit volume and in relation to urinary creatinine concentration
|
Day 1
|
Status of other micronutrients
Time Frame: Day 1
|
Concentrations of micronutrients in serum and breast milk (vitamins E, B1, B2, B3, B5, B6, B7)
|
Day 1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Micronutrient supplement use
Time Frame: Day 1
|
Reported use of daily or periodic micronutrient supplements in the past month
|
Day 1
|
Consumption of fruits and vegetables
Time Frame: Day 1
|
Assessed using the WHO STEPS questionnaire
|
Day 1
|
Consumption of snacks and sweetened beverages
Time Frame: Day 1
|
Assessed using the WHO STEPS questionnaire
|
Day 1
|
Physical activity
Time Frame: Day 1
|
Assessed using the WHO STEPS questionnaire
|
Day 1
|
Tobacco use
Time Frame: Day 1
|
Assessed using the WHO STEPS questionnaire
|
Day 1
|
Alcohol use
Time Frame: Day 1
|
Assessed using the WHO STEPS questionnaire
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1536100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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