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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 995
- 试验地点
- 1
- 主要终点
- Breast milk vitamin B12 concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Breast milk vitamin B12 concentration
时间窗: Day 1
Vitamin B12 concentration in breast milk
Total body vitamin A stores
时间窗: 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"
时间窗: 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
时间窗: Day 1
Hemoglobin concentration in venous blood (g/dL) among women and children
Themes from focus group discussions
时间窗: Day 1
Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues
Folate status
时间窗: Day 1
Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)
Zinc status
时间窗: Day 1
Serum zinc concentration among women and children
Urinary iodine concentration
时间窗: Day 1
Iodine concentration of urine among women and children
Recipe ingredients
时间窗: 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
时间窗: Day 1
Availability, price, and fortification levels of fortified food products in markets
Coefficient "Fa"
时间窗: 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.
Vitamin A status
时间窗: Day 1
Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children
Vitamin B12 status
时间窗: Day 1
Concentrations of vitamin B12 in serum among women and children
Breast milk vitamin A concentration
时间窗: Day 1
Vitamin A concentration in breast milk, expressed per unit volume and per gram fat
Iron status
时间窗: Day 1
Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children
Prevalence of anemia and micronutrient deficiencies
时间窗: Day 1
Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs
次要结局
- Hypertension(Day 1)
- Weight, kg(Day 1)
- Prevalence of undernutrition(Day 1)
- Prevalence of overweight and obesity(Day 1)
- Anthropometric Z-scores(Day 1)
- Morbidity symptoms(Day 1)
- Individual dietary intake(Day 1)
- Blood pressure(Day 1)
- Height, cm(Day 1)
- Waist to hip ratio(Day 1)
- Inflammation(Day 1)
- Status of other micronutrients(Day 1)
- Mid-upper arm circumference, cm(Day 1)
- Household-food consumption(Day 1)
- Urinary sodium concentration(Day 1)