Nutritional Status and Bouillon Use in Northern Ghana
- Conditions
- Folate DeficiencyAnemiaVitamin A DeficiencyDietary HabitsIron DeficiencyVitamin B 12 DeficiencyZinc Deficiency
- Interventions
- Other: N/A (observational study)
- Registration Number
- NCT04632771
- Lead Sponsor
- University of California, Davis
- Brief Summary
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.
- 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:
1. 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.
2. 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.
3. 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.
4. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 995
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Focus group discussions N/A (observational study) Focus group discussions conducted among women of reproductive age, older women, and men (n=120 total) RID Pilot 1 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) RID Pilot 2 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) Recipe observations N/A (observational study) Observations of cooking of local dishes by selected participants (n=50) enrolled in the pilot survey. Pilot survey: non-pregnant, non-lactating women N/A (observational study) Survey of non-pregnant, non-lactating women 15-49 years of age (n=250) Market assessment N/A (observational study) Survey of retail outlets selling fortified staple foods and/or bouillon (n=50 shop owners or operators) Pilot survey: children N/A (observational study) Survey of children 2-5 years of age (n=250) Pilot survey: lactating women 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)
- Primary Outcome Measures
Name Time Method Breast milk vitamin B12 concentration Day 1 Vitamin B12 concentration in breast milk
Total body vitamin A stores 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
Coefficient "S" 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.
Hemoglobin Day 1 Hemoglobin concentration in venous blood (g/dL) among women and children
Themes from focus group discussions Day 1 Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues
Folate status Day 1 Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)
Zinc status Day 1 Serum zinc concentration among women and children
Urinary iodine concentration Day 1 Iodine concentration of urine among women and children
Recipe ingredients 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
Fortified food accessibility Day 1 Availability, price, and fortification levels of fortified food products in markets
Coefficient "Fa" 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.
Iron status Day 1 Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children
Vitamin A status Day 1 Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children
Vitamin B12 status Day 1 Concentrations of vitamin B12 in serum among women and children
Breast milk vitamin A concentration Day 1 Vitamin A concentration in breast milk, expressed per unit volume and per gram fat
Prevalence of anemia and micronutrient deficiencies Day 1 Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs
- Secondary Outcome Measures
Name Time Method Hypertension Day 1 Prevalence of blood pressure measurements above cutoffs for hypertension
Weight, kg Day 1 Weight measurement among women and children
Prevalence of undernutrition Day 1 Prevalence of anthropometric Z-scores or mid-upper arm circumference below WHO cutoffs to indicate child undernutrition
Prevalence of overweight and obesity Day 1 Prevalence of body mass index (women) or BMI-for-age Z-score (children) above WHO cutoffs
Anthropometric Z-scores 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)
Morbidity symptoms Day 1 Reported malaria, diarrhea, fever, or vomiting in the past 7 days (all survey participants)
Individual dietary intake 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
Blood pressure Day 1 Blood pressure measured among women and children (mm Hg, systolic and diastolic)
Height, cm Day 1 Standing height measured among women and children
Waist to hip ratio Day 1 Waist and hip circumference (measured in cm) among women and their ratio
Inflammation Day 1 Serum concentrations of CRP, AGP, amyloid A, MCP-1, IL-6, IL-10, IL-1b, adiponectin
Status of other micronutrients Day 1 Concentrations of micronutrients in serum and breast milk (vitamins E, B1, B2, B3, B5, B6, B7)
Mid-upper arm circumference, cm Day 1 Mid-upper arm circumference measured among children
Household-food consumption 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
Urinary sodium concentration Day 1 Expressed per unit volume and in relation to urinary creatinine concentration
Trial Locations
- Locations (1)
University of Ghana
🇬🇭Accra, Ghana