- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05177614
Acceptability of Fortified Bouillon Cubes in Northern Ghana
A Study to Evaluate the Acceptability of a Multiple Micronutrient-fortified Bouillon Cube in Women and Their Households in Two Districts in the Northern Region of Ghana
Study Overview
Status
Conditions
Detailed Description
Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa, particularly among young children and women of reproductive age. Bouillon is a promising food fortification vehicle because the product is centrally processed on large scale, consumed by many households in West African countries (even rural, poor households), and consumed by most members of the household in relatively constant amounts. However, several important research questions remain regarding whether the use of fortified bouillon would be feasible, acceptable and effective for preventing micronutrient deficiencies in communities where such deficiencies are common.
Objectives: This study aims (1) to evaluate the acceptability of bouillon cubes formulated with 6 micronutrients for which deficiency is common among women and children in Ghana and (2) to access the feasibility and reliability of data collection methods to be used in a later study of the effects of fortified bouillon, compared to control, on micronutrient status, health, and development.
Methods: This acceptability study will be conducted in the Kumbungu and Tolon districts in the Northern Region, where a recent survey showed that micronutrient deficiencies were common. The investigators will recruit non-pregnant adult women (15+ years old) (n = 84) who are responsible for household meal preparation, to participate in sensory testing of an uncooked fortified bouillon as well as a cooked food containing the fortified bouillon. Subsequently, participants will receive a 14-day supply of fortified bouillon cubes to use at home, after which they will be asked their opinions about the bouillon. Three fortified bouillon formulations will be tested: 1) upper-level bouillon, fortified with iron, zinc, iodine, vitamin A, folic acid, and vitamin B-12, 2) lower-level bouillon, containing the same 6 micronutrients but with lower concentrations of some micronutrients, and 3) a control bouillon, fortified with iodine only. Participants will be in the study for approximately 18 days (study day 0 to study day 17). In addition, children 2-6 years of age in households of enrolled women will be eligible to participate in a pilot study to evaluate the feasibility and test-retest reliability of several methods to assess child development. For these children, child development will be assessed at two home visits during the 14-day period of fortified bouillon use at home.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Accra, Ghana
- University of Ghana
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Acceptability study:
- self-reported non-pregnant adult women (15+ years)
- responsible for meal preparation in the household
- signed the informed consent form
Child development assessment pilot sub-study:
- 2-6 years of age (24-71 months)
- residing in the same household as an enrolled woman
- child's primary caregiver signs the informed consent form
Exclusion Criteria:
- severe illness warranting immediate hospital referral
- COVID-19 exposure, positive test, or current symptoms (including fever, cough, shortness of breath, loss of smell, vomiting, or diarrhea [> 3 liquid or semi-liquid stools in 24h]) of illness
- chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status or affecting child development (children only)
- presence of ailments (such as toothache, or mouth pain) that may impact a participant's ability to complete study activities (women only)
- unable to provide informed consent due to impaired decision making abilities
- current participation in a clinical trial
- reported shrimp, wheat, milk, soy, eggs, celery, fish, or mollusc allergy, or a previous adverse reaction to bouillon by anyone in the household
- refusal to use provided bouillon cubes to prepare household meals while enrolled in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Upper-level multiple micronutrient-fortified bouillon cube
10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients
|
80 µg/g Folic acid 1.2 µg/g Vitamin B12 3 mg/g Zinc (ZnO) 4 mg/g Iron (FePP/citric acid/trisodium citrate) 200 µg/g Vitamin A (retinyl palmitate) 30 µg/g Iodine (KIO3)
|
Experimental: Lower-level multiple micronutrient-fortified bouillon cube
10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients
|
28.8 µg/g Folic acid 0.288 µg/g Vitamin B12 1.68 mg/g Zinc (ZnO) 1.3 mg/g Iron (FePP/citric acid/trisodium citrate) 96 µg/g Vitamin A (retinyl palmitate) 30 µg/g Iodine (KIO3)
|
Placebo Comparator: Control (iodine-fortified bouillon cube)
10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with one micronutrient
|
30 µg/g Iodine (KIO3)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory perceptions of multiple micronutrient-fortified bouillon cubes (uncooked)
Time Frame: Study day 1
|
|
Study day 1
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Sensory perceptions of a soup dish cooked with multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 1 or 2
|
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Study day 1 or 2
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Sensory perceptions of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 1 or 2
|
|
Study day 1 or 2
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Ability to discriminate among different multiple micronutrient-fortified bouillon cubes (uncooked)
Time Frame: Study day 1
|
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Study day 1
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Preference test of multiple micronutrient-fortified bouillon cubes (uncooked)
Time Frame: Study day 1
|
|
Study day 1
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Preference test of a soup dish cooked multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 1 or 2
|
|
Study day 1 or 2
|
Preference test of a rice-based dish cooked multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 1 or 2
|
|
Study day 1 or 2
|
Consumption of a soup dish cooked with multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 1 or 2
|
|
Study day 1 or 2
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Consumption of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 1 or 2
|
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Study day 1 or 2
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Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 17
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|
Study day 17
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Quantity of study-provided bouillon cubes used
Time Frame: Study day 17
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Study day 17
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Study-provided bouillon cube use as a proportion of total bouillon use
Time Frame: Study day 17
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Study day 17
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Change in child development scores on the Malawi Developmental Assessment Tool (MDAT)
Time Frame: From study day 3 to study day 17 (2 weeks)
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From study day 3 to study day 17 (2 weeks)
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Change in Responsive care and learning opportunities in the home environment: Home Observation for the Measurement of the Environment (HOME) Inventory score
Time Frame: From study day 3 to study day 17 (2 weeks)
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From study day 3 to study day 17 (2 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Household-level consumption of salt
Time Frame: Study day 0
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|
Study day 0
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Household-level consumption of bouillon
Time Frame: Study day 0
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Study day 0
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Change in willingness to pay for multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 1 and 17
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Study day 1 and 17
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Themes from focus group discussions
Time Frame: Study day 2 and 17
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Study day 2 and 17
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Perceived health effects of using study-provided multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 17
|
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Study day 17
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Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes
Time Frame: Study day 9
|
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Study day 9
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seth Adu-Afarwuah, PhD, University of Ghana
- Principal Investigator: Reina Engle-Stone, PhD, University of California, Davis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1687671
- 017/12/20 (Other Identifier: GHS-ERC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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