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Completed

NCT Number: NCT04632771

Nutritional Status and Bouillon Use in Northern Ghana

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N/A (Observational Study)

Other

N/A (observational study)

Primary outcomes

  1. Hemoglobin

    Time frame: Day 1

    Hemoglobin concentration in venous blood (g/dL) among women and children

  2. Iron status

    Time frame: Day 1

    Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children

  3. Vitamin A status

    Time frame: Day 1

    Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children

  4. Vitamin B12 status

    Time frame: Day 1

    Concentrations of vitamin B12 in serum among women and children

  5. Folate status

    Time frame: Day 1

    Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)

  6. Zinc status

    Time frame: Day 1

    Serum zinc concentration among women and children

  7. Breast milk vitamin A concentration

    Time frame: Day 1

    Vitamin A concentration in breast milk, expressed per unit volume and per gram fat

  8. Breast milk vitamin B12 concentration

    Time frame: Day 1

    Vitamin B12 concentration in breast milk

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. Prevalence of anemia and micronutrient deficiencies

    Time frame: Day 1

    Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs

  14. Urinary iodine concentration

    Time frame: Day 1

    Iodine concentration of urine among women and children

  15. 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

  16. 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

  17. Fortified food accessibility

    Time frame: Day 1

    Availability, price, and fortification levels of fortified food products in markets

Secondary outcomes

  1. Blood pressure

    Time frame: Day 1

    Blood pressure measured among women and children (mm Hg, systolic and diastolic)

  2. Hypertension

    Time frame: Day 1

    Prevalence of blood pressure measurements above cutoffs for hypertension

  3. Height, cm

    Time frame: Day 1

    Standing height measured among women and children

  4. Weight, kg

    Time frame: Day 1

    Weight measurement among women and children

  5. Waist to hip ratio

    Time frame: Day 1

    Waist and hip circumference (measured in cm) among women and their ratio

  6. Mid-upper arm circumference, cm

    Time frame: Day 1

    Mid-upper arm circumference measured among children

  7. 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)

  8. Prevalence of undernutrition

    Time frame: Day 1

    Prevalence of anthropometric Z-scores or mid-upper arm circumference below WHO cutoffs to indicate child undernutrition

  9. 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

  10. Morbidity symptoms

    Time frame: Day 1

    Reported malaria, diarrhea, fever, or vomiting in the past 7 days (all survey participants)

  11. Inflammation

    Time frame: Day 1

    Serum concentrations of CRP, AGP, amyloid A, MCP-1, IL-6, IL-10, IL-1b, adiponectin

  12. 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

  13. 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

  14. Urinary sodium concentration

    Time frame: Day 1

    Expressed per unit volume and in relation to urinary creatinine concentration

  15. Status of other micronutrients

    Time frame: Day 1

    Concentrations of micronutrients in serum and breast milk (vitamins E, B1, B2, B3, B5, B6, B7)

Other outcomes

  1. Micronutrient supplement use

    Time frame: Day 1

    Reported use of daily or periodic micronutrient supplements in the past month

  2. Consumption of fruits and vegetables

    Time frame: Day 1

    Assessed using the WHO STEPS questionnaire

  3. Consumption of snacks and sweetened beverages

    Time frame: Day 1

    Assessed using the WHO STEPS questionnaire

  4. Physical activity

    Time frame: Day 1

    Assessed using the WHO STEPS questionnaire

  5. Tobacco use

    Time frame: Day 1

    Assessed using the WHO STEPS questionnaire

  6. Alcohol use

    Time frame: Day 1

    Assessed using the WHO STEPS questionnaire

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Helen Keller International
  • Newcastle University
  • Penn State University
  • University of Ghana

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2020
Registry last updated
Apr 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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