Nutritional Status and Bouillon Use in Northern Ghana

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632771
• Other study ID #: 1536100
• Status: Completed
• Start date: October 19, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 995
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Dietary Habits
• Folate Deficiency
• Folic Acid Deficiency
• Iron Deficiency
• Night Blindness
• Vitamin A Deficiency
• Vitamin B 12 Deficiency
• Zinc Deficiency

Intervention

Other:
• N/A (observational study)
N/A (observational study)

Locations

Country	Name	City	State
Ghana	University of Ghana	Accra

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Davis	Helen Keller International, Newcastle University, Penn State University, University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Micronutrient supplement use	Reported use of daily or periodic micronutrient supplements in the past month	Day 1
Other	Consumption of fruits and vegetables	Assessed using the WHO STEPS questionnaire	Day 1
Other	Consumption of snacks and sweetened beverages	Assessed using the WHO STEPS questionnaire	Day 1
Other	Physical activity	Assessed using the WHO STEPS questionnaire	Day 1
Other	Tobacco use	Assessed using the WHO STEPS questionnaire	Day 1
Other	Alcohol use	Assessed using the WHO STEPS questionnaire	Day 1
Primary	Hemoglobin	Hemoglobin concentration in venous blood (g/dL) among women and children	Day 1
Primary	Iron status	Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children	Day 1
Primary	Vitamin A status	Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children	Day 1
Primary	Vitamin B12 status	Concentrations of vitamin B12 in serum among women and children	Day 1
Primary	Folate status	Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)	Day 1
Primary	Zinc status	Serum zinc concentration among women and children	Day 1
Primary	Breast milk vitamin A concentration	Vitamin A concentration in breast milk, expressed per unit volume and per gram fat	Day 1
Primary	Breast milk vitamin B12 concentration	Vitamin B12 concentration in breast milk	Day 1
Primary	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	Day 7
Primary	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	Day 14
Primary	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.	Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
Primary	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.	Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
Primary	Prevalence of anemia and micronutrient deficiencies	Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs	Day 1
Primary	Urinary iodine concentration	Iodine concentration of urine among women and children	Day 1
Primary	Themes from focus group discussions	Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues	Day 1
Primary	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	Day 1
Primary	Fortified food accessibility	Availability, price, and fortification levels of fortified food products in markets	Day 1
Secondary	Blood pressure	Blood pressure measured among women and children (mm Hg, systolic and diastolic)	Day 1
Secondary	Hypertension	Prevalence of blood pressure measurements above cutoffs for hypertension	Day 1
Secondary	Height, cm	Standing height measured among women and children	Day 1
Secondary	Weight, kg	Weight measurement among women and children	Day 1
Secondary	Waist to hip ratio	Waist and hip circumference (measured in cm) among women and their ratio	Day 1
Secondary	Mid-upper arm circumference, cm	Mid-upper arm circumference measured among children	Day 1
Secondary	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)	Day 1
Secondary	Prevalence of undernutrition	Prevalence of anthropometric Z-scores or mid-upper arm circumference below WHO cutoffs to indicate child undernutrition	Day 1
Secondary	Prevalence of overweight and obesity	Prevalence of body mass index (women) or BMI-for-age Z-score (children) above WHO cutoffs	Day 1
Secondary	Morbidity symptoms	Reported malaria, diarrhea, fever, or vomiting in the past 7 days (all survey participants)	Day 1
Secondary	Inflammation	Serum concentrations of CRP, AGP, amyloid A, MCP-1, IL-6, IL-10, IL-1b, adiponectin	Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	Urinary sodium concentration	Expressed per unit volume and in relation to urinary creatinine concentration	Day 1
Secondary	Status of other micronutrients	Concentrations of micronutrients in serum and breast milk (vitamins E, B1, B2, B3, B5, B6, B7)	Day 1