Clinical trial NCT04632771: Nutritional Status and Bouillon Use in Northern Ghana
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency
Vitamin A Deficiency
Vitamin B 12 Deficiency
Folate Deficiency
Zinc Deficiency
Dietary Habits
Anemia
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: Newcastle University
name: Penn State University
name: Helen Keller International
First posted: 2020-11-17
Enrollment: 995
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Households in the urban and rural areas in Tolon and Kumbungu districts, in northern Ghana

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.

Eligibility 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

Primary outcomes:
measure: Hemoglobin
timeFrame: Day 1
measure: Iron status
timeFrame: Day 1
measure: Vitamin A status
timeFrame: Day 1
measure: Vitamin B12 status
timeFrame: Day 1
measure: Folate status
timeFrame: Day 1
measure: Zinc status
timeFrame: Day 1
measure: Breast milk vitamin A concentration
timeFrame: Day 1
measure: Breast milk vitamin B12 concentration
timeFrame: Day 1
measure: Total body vitamin A stores
timeFrame: Day 7
measure: Total body vitamin A stores
timeFrame: Day 14
measure: Coefficient "Fa"
timeFrame: Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
measure: Coefficient "S"
timeFrame: Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
measure: Prevalence of anemia and micronutrient deficiencies
timeFrame: Day 1
measure: Urinary iodine concentration
timeFrame: Day 1
measure: Themes from focus group discussions
timeFrame: Day 1
measure: Recipe ingredients
timeFrame: Day 1
measure: Fortified food accessibility
timeFrame: Day 1
Secondary outcomes:
measure: Blood pressure
timeFrame: Day 1
measure: Hypertension
timeFrame: Day 1
measure: Height, cm
timeFrame: Day 1
measure: Weight, kg
timeFrame: Day 1
measure: Waist to hip ratio
timeFrame: Day 1
measure: Mid-upper arm circumference, cm
timeFrame: Day 1
measure: Anthropometric Z-scores
timeFrame: Day 1
measure: Prevalence of undernutrition
timeFrame: Day 1
measure: Prevalence of overweight and obesity
timeFrame: Day 1
measure: Morbidity symptoms
timeFrame: Day 1
measure: Inflammation
timeFrame: Day 1
measure: Household-food consumption
timeFrame: Day 1
measure: Individual dietary intake
timeFrame: Day 1
measure: Urinary sodium concentration
timeFrame: Day 1
measure: Status of other micronutrients
timeFrame: Day 1
Other outcomes:
measure: Micronutrient supplement use
timeFrame: Day 1
measure: Consumption of fruits and vegetables
timeFrame: Day 1
measure: Consumption of snacks and sweetened beverages
timeFrame: Day 1
measure: Physical activity
timeFrame: Day 1
measure: Tobacco use
timeFrame: Day 1
measure: Alcohol use
timeFrame: Day 1
Locations:
city: Accra
country: Ghana
facility: University of Ghana
Study officials:
References: