Nutritional Status and Bouillon Use in Northern Ghana

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

995 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-19

Study Completion Date

2022-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Iron Deficiency Vitamin A Deficiency Vitamin B 12 Deficiency Folate Deficiency Zinc Deficiency Dietary Habits Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pilot survey: non-pregnant, non-lactating women

Survey of non-pregnant, non-lactating women 15-49 years of age (n=250)

N/A (observational study)

Intervention Type OTHER

N/A (observational study)

Pilot survey: lactating women

Survey of lactating women 15-49 years of age who are currently breastfeeding a child 4-18 months of age (n=250)

N/A (observational study)

Intervention Type OTHER

N/A (observational study)

Pilot survey: children

Survey of children 2-5 years of age (n=250)

N/A (observational study)

Intervention Type OTHER

N/A (observational study)

RID Pilot 1

Two-week study to assess total body vitamin A stores in a sample of non-pregnant, non-lactating women 15-49 years of age (n=30)

N/A (observational study)

Intervention Type OTHER

N/A (observational study)

RID Pilot 2

Kinetic study with "Super-woman" design to develop a prediction equation to assess total body vitamin A stores among non-pregnant, non-lactating women 15-49 years of age (n=123)

N/A (observational study)

Intervention Type OTHER

N/A (observational study)

Focus group discussions

Focus group discussions conducted among women of reproductive age, older women, and men (n=120 total)

N/A (observational study)

Intervention Type OTHER

N/A (observational study)

Market assessment

Survey of retail outlets selling fortified staple foods and/or bouillon (n=50 shop owners or operators)

N/A (observational study)

Intervention Type OTHER

N/A (observational study)

Recipe observations

Observations of cooking of local dishes by selected participants (n=50) enrolled in the pilot survey.

N/A (observational study)

Intervention Type OTHER

N/A (observational study)

Interventions

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N/A (observational study)

Intervention Type OTHER

Eligibility Criteria

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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)

* 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

* 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

* Adults (including women, men, and other key community members such as merchants, etc.)
* Provision of written informed consent

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

* 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

* 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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes