Vitamin A DeficiencyNCT05178407
Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
A study testing Multiple micronutrient-fortified bouillon cube in people with Vitamin A Deficiency and Iron-deficiency, run by University of California, Davis at 1 site in Ghana.
Trial summary
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 most households in West African countries… Read more about this study
- Who is it for?
- Ages 2 to 49 years
- Conditions the study is for
- Vitamin A Deficiency, Iron-deficiency, Folate Deficiency
- What is being tested?
- Multiple micronutrient-fortified bouillon cube
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,372 participants
- Where
- 1 siteGhana
- Study dates
- 16 Jan 2023to 12 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Household
- Head of household provides oral consent for the participation of household members (index participants), and willingness to have study-provided bouillon cubes used in their household for the next 10 months.
- Non-pregnant non-lactating women of reproductive age (15 - 49 years);
- Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, assent provided from the index participant and consent from a parent or guardian) ;
- Planning to remain in the study area for the next 10 months;
- Willing to use study-provided bouillon in household cooking for the next 10 months;
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- Not planning to become pregnant during the next 10 months.
- Child 2-5 years of age (24-59 mo);
- Signed informed consent for the child's participation from a parent or guardian;
- Planning to remain in the study area for the next 10 months;
- Caregiver willing to use study-provided bouillon in household cooking for the next 10 months.
- Non-pregnant women of reproductive age (15 - 49 years), currently breastfeeding a child who is 4-18 months of age;
- Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, provide assent from the index participant and consent from a parent or guardian);
- Planning to remain in the study area for the next 4 months;
- Planning to breastfeed for the next 4 months;
- Willing to use study-provided bouillon in household cooking for the next 4 months;
- Not planning to become pregnant during the next 4 months.
Who cannot join
- Reported chronic medical condition requiring frequent blood transfusion (e.g. severe forms of thalassemia) among any household members;
- Current participation of any household member in a clinical trial;
- Reported shrimp, wheat, milk, soy, eggs, celery, fish, or mollusk allergy, or a previous adverse reaction to bouillon by the participant or any member of their household.
- Non-pregnant, non-lactating women of reproductive age
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
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- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status;
- Unable to provide informed consent due to impaired decision-making abilities.
- Children 2-5 years of age (24-59 mo)
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever, [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Mid-upper arm circumference < 11.5 cm;
- Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status.
- Lactating women
- Pregnancy (determined by self-report);
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever[temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status;
- Unable to provide informed consent due to impaired decision-making abilities.
- Exclusion criteria at screening visit for vitamin A isotope dose (WRA only):
- Non-pregnant, non-lactating women of reproductive age
- Hemoglobin < 80 g/L at baseline screening visit;
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Recent diarrhea [≥3 liquid or semiliquid stools in 72 hours]) [individual may repeat eligibility assessment after deferral];
- Reported consumption of vitamin A-rich foods (e.g., liver) in the previous 24 hours [individual may repeat eligibility assessment after deferral];
- Pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin on the day of isotope dosing);
- Incomplete consumption of vitamin A isotope dose;
- Positive malaria RDT on the day of isotope dosing [individual may repeat eligibility assessment after deferral];
- CRP > 5 mg/L on the day of isotope dosing [individual may repeat eligibility assessment after deferral].
- Non-pregnant, non-lactating women of reproductive age
- Hemoglobin < 80 g/L;
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Pregnancy (determined by self-report).
- Children 2-5 years of age
- Hemoglobin < 70 g/L;
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after referral];
- Severe acute malnutrition at baseline (weight-for-height Z-score < -3 SD or bilateral oedema).
- Lactating women
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, or loss of taste or smell within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Pregnancy (determined by self-report);
- Cessation of lactation, or planning to discontinue breastfeeding in the next three months.
- Non-pregnant, non-lactating women of reproductive age
- Pregnancy (determined by self-report);
- Pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin at pre-endline isotope dosing).
- Lactating women
- Cessation of lactation (determined by self-report);
- Pregnancy (determined by self-report).
Trial locations and contacts
1 site in 1 country.
About this study
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 most 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 and effective for preventing or reducing micronutrient deficiencies in communities where such deficiencies are common. Specifically, no studies have assessed the impacts of multiple micronutrient-fortified bouillon on micronutrient status. The West Africa Condiment Micronutrient Innovation Trial (CoMIT) Project aims to address this gap, to inform future discussions around fortification of bouillon cubes and related products.
Objective: This study aims to assess the impacts of household use of multiple micronutrient-fortified bouillon cubes (containing iodine in addition to vitamin A, folic acid, vitamin B12, iron, and zinc), compared to control bouillon cubes fortified with iodine only, on:
Read more
- Micronutrient status among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
- Hemoglobin concentrations among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
- Breast milk micronutrient concentrations among lactating women 4-18 months postpartum after 3 months of intervention
Methods: This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate that deficiencies in the selected nutrients are common. Potential participants will be: 1) non-pregnant non-lactating women of reproductive age (15 - 49 years old), 2) children 2-5 years of age, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes:
- a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or
- a control cube containing iodine only
Each participant's household will receive a specific amount of bouillon cube every 2 weeks, and households will be advised to prepare their meals as usual, using the study-provided cubes. The trial duration will be 9 months (38 weeks) for non-pregnant, non-lactating women and children 2-5 years of age, and 3 months (12 weeks) for lactating women. The primary outcomes will be changes from baseline to endline in concentrations of haemoglobin and biomarkers of micronutrient status. Secondary outcomes will include change in prevalence of anaemia and micronutrient deficiency; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and children's anthropometric measures and child development.
- Conditions
- Vitamin A Deficiency, Iron-deficiency, Folate Deficiency, Vitamin B 12 Deficiency, Zinc Deficiency, Anemia
- Being tested
- Multiple micronutrient-fortified bouillon cube, Control bouillon cube (iodine-only)
- Keywords
- Micronutrient, Food Fortification,
- Medical subject headings
- Vitamin A Deficiency, Anemia, Iron-Deficiency, Folic Acid Deficiency, Vitamin B 12 Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrient-fortified bouillon cubeDietary supplement
Bouillon cube fortified with 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)
Control bouillon cube (iodine-only)Dietary supplement
Bouillon cube fortified with 30 µg/g Iodine (KIO3)
| Study group | Role | What they receive |
|---|---|---|
| Multiple micronutrient-fortified bouillon cube | Experimental | 10-gram shrimp-flavoured bouillon cube, fortified with 6 micronutrients
Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum). Receives: Dietary Supplement: Multiple micronutrient-fortified bouillon cube |
| Control bouillon cube (iodine only) | Placebo comparator | 10-gram shrimp-flavoured bouillon cube, fortified with iodine
Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum). Receives: Dietary Supplement: Control bouillon cube (iodine-only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin A status among non-pregnant, non-lactating women
Total body vitamin A stores and estimated liver vitamin A concentration measured by retinol isotope dilution at baseline and endline
Measured: 38 weeks
Change in vitamin A status among children 2-5 years
Plasma retinol-binding protein (RBP) concentrations, measured at baseline and endline
Measured: 38 weeks
Change in vitamin A status among lactating women 4-18 mo postpartum
Breast milk vitamin A concentration and vitamin A per gram fat, measured at baseline and endline
Measured: 12 weeks
Change in iron status among non-pregnant, non-lactating women
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Measured: 38 weeks
Change in iron status among children 2-5 years
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Measured: 38 weeks
Change in hemoglobin concentration among non-pregnant, non-lactating women
Hemoglobin concentration measured in venous blood at baseline and endline
Measured: 38 weeks
Change in hemoglobin concentration among children 2-5 years
Hemoglobin concentration measured in venous blood at baseline and endline
Measured: 38 weeks
Change in zinc status among non-pregnant, non-lactating women
Plasma zinc measured at baseline and endline
Measured: 38 weeks
Change in zinc status among children 2-5 years
Plasma zinc measured at baseline and endline
Measured: 38 weeks
Change in folate status among non-pregnant, non-lactating women
Erythrocyte folate concentrations, calculated from whole blood folate and serum folate concentrations, measured at baseline and endline
Measured: 38 weeks
Change in folate status among children 2-5 years
Plasma folate concentrations, measured at baseline and endline
Measured: 38 weeks
Change in vitamin B12 status among non-pregnant, non-lactating women
Plasma vitamin B12 concentrations, measured at baseline and endline
Measured: 38 weeks
Change in vitamin B12 status among children 2-5 years
Plasma vitamin B12 concentrations, measured at baseline and endline
Measured: 38 weeks
Change in vitamin B12 status among lactating women 4-18 months postpartum
Breast milk vitamin B12 concentrations, measured at baseline and endline
Measured: 12 weeks
Secondary outcomes (32)
Average daily household consumption of bouillon
Assessed biweekly by questionnaire, observed stocks, and wrapper counts.
Measured: 38 weeks
Adherence to study-provided bouillon
Consumption of study-provided bouillon cubes, expressed as percentage of all bouillon consumed by the household, and as percentage of study-provided consumed by the household, assessed biweekly by questionnaire, observed stocks, and wrapper counts
Measured: 38 weeks
Change in vitamin A status markers among non-pregnant, non-lactating women
Plasma or serum retinol and retinol-binding protein (RBP) concentrations, measured at baseline and endline
Measured: 38 weeks
Change in serum folate concentration among non-pregnant, non-lactating women
Serum folate concentration, measured at baseline and endline
Measured: 38 weeks
Change in plasma retinol concentration among children 2-5 years
Measured at baseline and endline
Measured: 38 weeks
Change in iodine status among non-pregnant, non-lactating women
Urinary iodine concentration, measured at baseline and endline
Measured: 38 weeks
Change in iodine status among children 2-5 years
Urinary iodine concentration, measured at baseline and endline
Measured: 38 weeks
Change in iodine status among lactating women 4-18 months postpartum
Urinary iodine concentration, measured at baseline and endline
Measured: 12 weeks
Change in urinary sodium concentrations among non-pregnant, non-lactating women
Urinary sodium concentration, expressed as sodium:potassium ratio, measured at baseline and endline
Measured: 38 weeks
Change in inflammation among non-pregnant, non-lactating women
Plasma concentrations of acute phase proteins, measured at baseline and endline
Measured: 38 weeks
Change in inflammation among children 2-5 years
Plasma concentrations of acute phase proteins, measured at baseline and endline
Measured: 38 weeks
Change in current or recent malaria among non-pregnant, non-lactating women
Assessed by rapid diagnostic test at baseline and endline
Measured: 38 weeks
Change in current or recent malaria among children 2-5 years
Assessed by rapid diagnostic test at baseline and endline
Measured: 38 weeks
Morbidity among non-pregnant, non-lactating women
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Measured: 38 weeks
Morbidity among children 2-5 years
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Measured: 38 weeks
Morbidity among lactating women 4-18 months postpartum
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Measured: 12 weeks
Change in dietary intake among non-pregnant, non-lactating women
Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline and endline
Measured: 38 weeks
Change in dietary intake among children 2-5 years
Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline and endline
Measured: 38 weeks
Dietary intake among lactating women 4-18 months postpartum
Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline
Measured: 4 weeks
Change in anemia among non-pregnant, non-lactating women
Hemoglobin concentrations < 12 g/dL, measured at baseline and endline
Measured: 38 weeks
Change in anemia among children 2-5 years
Hemoglobin concentrations < 11 g/dL, measured at baseline and endline
Measured: 38 weeks
Change in micronutrient deficiency among non-pregnant, non-lactating women
Based on biomarkers of micronutrient status (vitamin A, iron, zinc, folate, vitamin B12), measured at baseline and endline
Measured: 38 weeks
Change in micronutrient deficiency among children 2-5 years
Based on biomarkers of micronutrient status (vitamin A, iron, zinc, folate, vitamin B12), measured at baseline and endline
Measured: 38 weeks
Change in low milk nutrient concentrations among lactating women 4-18 months postpartum
Based on concentrations of vitamin A and vitamin B12, measured at baseline and endline
Measured: 12 weeks
Systolic and diastolic blood pressure among non-pregnant, non-lactating women
Assessed by portable device
Measured: 38 weeks
Hypertension among non-pregnant, non-lactating women
Based on blood pressure measured by portable device
Measured: 38 weeks
Change in faecal calprotectin concentrations among children 2-5 years
Stool samples collected at baseline and endline
Measured: 38 weeks
Change in height-for-age Z score and stunting (HAZ < -2) among children 2-5 years
Standing height, standardized using WHO child growth standards
Measured: 38 weeks
Change in weight-for-height Z score and wasting (WHZ < -2) among children 2-5 years
Standardized using WHO child growth standards
Measured: 38 weeks
Change in cognitive development among children 2-5 years
Malawi Developmental Assessment Tool (MDAT) scores in 4 domains (gross motor, fine motor, language, social)
Measured: 38 weeks
Fecal microbiota among children 2-5 years
Stool samples collected at baseline and endline
Measured: 38 weeks
Change in cognitive development among children 2-5 years
Early Years Toolbox scores at baseline and endline
Measured: 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start16 Jan 2023
- Primary completion10 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghana, Newcastle University, Penn State University, Helen Keller International
- Responsible party
- Sponsor
- Investigators
- Reina Engle-Stone, PhD, Principal investigator, Department of Nutrition, UC DavisSeth Adu-Afarwuah, PhD, Principal investigator, University of Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178407
- Sponsor's protocol ID
- 1837253
- Status last verified
- Jul 2024
- First submitted
- 29 Nov 2021
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will commit to Global Access. The investigators intend to 1) publish journal articles describing the study results with an Open Access license, 2) make available information about study methods, such as protocols or standard operating procedures, on the study website, and 3) make available de-identified datasets upon request by the study sponsor or other investigators. Material/DataTransfer Agreements will be developed between study collaborators, sponsor, and any organizations that may request the data; terms of the agreement will be subject to the data handling and storage procedures approved by the University of California, Davis Institutional Review Board (IRB) and Ghana Health Services Ethical Review Committee (GHS-ERC). Organizations that may request the data; terms of the agreement will be subject to the data handling and storage procedures approved by the University of California, Davis IRB and GHS-ERC.
Publications
Kyereh FK, Ohemeng AN, Engle-Stone R, Wessells KR, Kumordzie SM, Arnold CD, Davis JN, Becher ER, Fuseini AD, Nyaaba KW, Tan X, Vosti SA, Adu-Afarwuah S. Perception and acceptance of micronutrient-Fortified Bouillon among Non-Index Household Members: A longitudinal sub-study nested within a randomized trial in Northern Ghana. PLoS One. 2026 Apr 3;21(4):e0345106. doi: 10.1371/journal.pone.0345106. eCollection 2026.
PubMed 41931601Engle-Stone R, Wessells KR, Haskell MJ, Kumordzie SM, Arnold CD, Davis JN, Becher ER, Fuseini AD, Nyaaba KW, Tan X, Adams KP, Lietz G, Vosti SA, Adu-Afarwuah S. Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial. PLoS One. 2024 May 6;19(5):e0302968. doi: 10.1371/journal.pone.0302968. eCollection 2024.
PubMed 38709803
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
- ClinicalTrials.gov ID
- NCT05178407
- Acronym / sponsor ID
- 1837253
- Conditions
- Vitamin A Deficiency, Iron-deficiency, Folate Deficiency, Vitamin B 12 Deficiency, Zinc Deficiency, Anemia
- Keywords
- Micronutrient, Food Fortification,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,372 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of Ghana, Newcastle University, Penn State University, Helen Keller International
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 most 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 and effective for preventing or reducing micronutrient deficiencies in communities where such deficiencies are common. Specifically, no studies have assessed the impacts of multiple micronutrient-fortified bouillon on micronutrient status. The West Africa Condiment Micronutrient Innovation Trial (CoMIT) Project aims to address this gap, to inform future discussions around fortification of bouillon cubes and related products.
Objective: This study aims to assess the impacts of household use of multiple micronutrient-fortified bouillon cubes (containing iodine in addition to vitamin A, folic acid, vitamin B12, iron, and zinc), compared to control bouillon cubes fortified with iodine only, on:
- Micronutrient status among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
- Hemoglobin concentrations among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
- Breast milk micronutrient concentrations among lactating women 4-18 months postpartum after 3 months of intervention
Methods: This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate that deficiencies in the selected nutrients are common. Potential participants will be: 1) non-pregnant non-lactating women of reproductive age (15 - 49 years old), 2) children 2-5 years of age, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes:
- a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or
- a control cube containing iodine only
Each participant's household will receive a specific amount of bouillon cube every 2 weeks, and households will be advised to prepare their meals as usual, using the study-provided cubes. The trial duration will be 9 months (38 weeks) for non-pregnant, non-lactating women and children 2-5 years of age, and 3 months (12 weeks) for lactating women. The primary outcomes will be changes from baseline to endline in concentrations of haemoglobin and biomarkers of micronutrient status. Secondary outcomes will include change in prevalence of anaemia and micronutrient deficiency; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and children's anthropometric measures and child development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple micronutrient-fortified bouillon cube | Experimental | Dietary Supplement: Multiple micronutrient-fortified bouillon cube10-gram shrimp-flavoured bouillon cube, fortified with 6 micronutrients Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum). |
| Control bouillon cube (iodine only) | Placebo comparator | Dietary Supplement: Control bouillon cube (iodine-only)10-gram shrimp-flavoured bouillon cube, fortified with iodine Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum). |
Who may qualify
- Ages
- 2 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Household
- Head of household provides oral consent for the participation of household members (index participants), and willingness to have study-provided bouillon cubes used in their household for the next 10 months.
- Non-pregnant non-lactating women of reproductive age (15 - 49 years);
- Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, assent provided from the index participant and consent from a parent or guardian) ;
- Planning to remain in the study area for the next 10 months;
Key exclusion criteria (58 listed)
- Reported chronic medical condition requiring frequent blood transfusion (e.g. severe forms of thalassemia) among any household members;
- Current participation of any household member in a clinical trial;
- Reported shrimp, wheat, milk, soy, eggs, celery, fish, or mollusk allergy, or a previous adverse reaction to bouillon by the participant or any member of their household.
- Non-pregnant, non-lactating women of reproductive age
- Severe illness warranting immediate hospital referral;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple micronutrient-fortified bouillon cubeBouillon cube fortified with 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) | Dietary supplement | Multiple micronutrient-fortified bouillon cube |
| Control bouillon cube (iodine-only)Bouillon cube fortified with 30 µg/g Iodine (KIO3) | Dietary supplement | Control bouillon cube (iodine only) |
Primary outcome
Change in vitamin A status among non-pregnant, non-lactating women
Time frame: 38 weeks
Total body vitamin A stores and estimated liver vitamin A concentration measured by retinol isotope dilution at baseline and endline
Change in vitamin A status among children 2-5 years
Time frame: 38 weeks
Plasma retinol-binding protein (RBP) concentrations, measured at baseline and endline
Change in vitamin A status among lactating women 4-18 mo postpartum
Time frame: 12 weeks
Breast milk vitamin A concentration and vitamin A per gram fat, measured at baseline and endline
Change in iron status among non-pregnant, non-lactating women
Time frame: 38 weeks
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Change in iron status among children 2-5 years
Time frame: 38 weeks
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Change in hemoglobin concentration among non-pregnant, non-lactating women
Time frame: 38 weeks
Hemoglobin concentration measured in venous blood at baseline and endline
Change in hemoglobin concentration among children 2-5 years
Time frame: 38 weeks
Hemoglobin concentration measured in venous blood at baseline and endline
Change in zinc status among non-pregnant, non-lactating women
Time frame: 38 weeks
Plasma zinc measured at baseline and endline
Change in zinc status among children 2-5 years
Time frame: 38 weeks
Plasma zinc measured at baseline and endline
Change in folate status among non-pregnant, non-lactating women
Time frame: 38 weeks
Erythrocyte folate concentrations, calculated from whole blood folate and serum folate concentrations, measured at baseline and endline
Change in folate status among children 2-5 years
Time frame: 38 weeks
Plasma folate concentrations, measured at baseline and endline
Change in vitamin B12 status among non-pregnant, non-lactating women
Time frame: 38 weeks
Plasma vitamin B12 concentrations, measured at baseline and endline
Change in vitamin B12 status among children 2-5 years
Time frame: 38 weeks
Plasma vitamin B12 concentrations, measured at baseline and endline
Change in vitamin B12 status among lactating women 4-18 months postpartum
Time frame: 12 weeks
Breast milk vitamin B12 concentrations, measured at baseline and endline
32 secondary outcomes
Average daily household consumption of bouillon
Time frame: 38 weeks
Adherence to study-provided bouillon
Time frame: 38 weeks
Change in vitamin A status markers among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in serum folate concentration among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in plasma retinol concentration among children 2-5 years
Time frame: 38 weeks
Change in iodine status among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in iodine status among children 2-5 years
Time frame: 38 weeks
Change in iodine status among lactating women 4-18 months postpartum
Time frame: 12 weeks
Change in urinary sodium concentrations among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in inflammation among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in inflammation among children 2-5 years
Time frame: 38 weeks
Change in current or recent malaria among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in current or recent malaria among children 2-5 years
Time frame: 38 weeks
Morbidity among non-pregnant, non-lactating women
Time frame: 38 weeks
Morbidity among children 2-5 years
Time frame: 38 weeks
Morbidity among lactating women 4-18 months postpartum
Time frame: 12 weeks
Change in dietary intake among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in dietary intake among children 2-5 years
Time frame: 38 weeks
Dietary intake among lactating women 4-18 months postpartum
Time frame: 4 weeks
Change in anemia among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in anemia among children 2-5 years
Time frame: 38 weeks
Change in micronutrient deficiency among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in micronutrient deficiency among children 2-5 years
Time frame: 38 weeks
Change in low milk nutrient concentrations among lactating women 4-18 months postpartum
Time frame: 12 weeks
Systolic and diastolic blood pressure among non-pregnant, non-lactating women
Time frame: 38 weeks
Hypertension among non-pregnant, non-lactating women
Time frame: 38 weeks
Change in faecal calprotectin concentrations among children 2-5 years
Time frame: 38 weeks
Change in height-for-age Z score and stunting (HAZ < -2) among children 2-5 years
Time frame: 38 weeks
Change in weight-for-height Z score and wasting (WHZ < -2) among children 2-5 years
Time frame: 38 weeks
Change in cognitive development among children 2-5 years
Time frame: 38 weeks
Fecal microbiota among children 2-5 years
Time frame: 38 weeks
Change in cognitive development among children 2-5 years
Time frame: 38 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 41931601Kyereh FK, Ohemeng AN, Engle-Stone R, Wessells KR, Kumordzie SM, Arnold CD, Davis JN, Becher ER, Fuseini AD, Nyaaba KW, Tan X, Vosti SA, Adu-Afarwuah S. Perception and acceptance of micronutrient-Fortified Bouillon among Non-Index Household Members: A longitudinal sub-study nested within a randomized trial in Northern Ghana. PLoS One. 2026 Apr 3;21(4):e0345106. doi: 10.1371/journal.pone.0345106. eCollection 2026.
- Derived from this study: PubMed 38709803Engle-Stone R, Wessells KR, Haskell MJ, Kumordzie SM, Arnold CD, Davis JN, Becher ER, Fuseini AD, Nyaaba KW, Tan X, Adams KP, Lietz G, Vosti SA, Adu-Afarwuah S. Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial. PLoS One. 2024 May 6;19(5):e0302968. doi: 10.1371/journal.pone.0302968. eCollection 2024.
- Individual participant dataSharing planned: Undecided. The investigators will commit to Global Access. The investigators intend to 1) publish journal articles describing the study results with an Open Access license, 2) make available information about study methods, such as protocols or standard operating procedures, on the study website, and 3) make available de-identified datasets upon request by the study sponsor or other investigators. Material/DataTransfer Agreements will be developed between study collaborators, sponsor, and any organizations that may request the data; terms of the agreement will be subject to the data handling and storage procedures approved by the University of California, Davis Institutional Review Board (IRB) and Ghana Health Services Ethical Review Committee (GHS-ERC). Organizations that may request the data; terms of the agreement will be subject to the data handling and storage procedures approved by the University of California, Davis IRB and GHS-ERC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reina Engle-Stone, PhD principal investigator
Department of Nutrition, UC Davis
Seth Adu-Afarwuah, PhD principal investigator
University of Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple micronutrient-fortified bouillon cube in people with Vitamin A Deficiency and Iron-deficiency, run by University of California, Davis at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 58 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vitamin A status among non-pregnant, non-lactating women (time frame: 38 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05178407, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.