Nutritional Status and Bouillon Use in Northern Ghana
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About
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.
Full 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.
Enrollment
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Inclusion and exclusion criteria
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
Trial design
995 participants in 8 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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