CompletedNCT05178407Updated Jul 12, 2024

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

An interventional study of Multiple micronutrient-fortified bouillon cube and Control bouillon cube (iodine-only) in Vitamin A Deficiency, Iron-deficiency and Folate Deficiency, sponsored by University of California, Davis. Completed at 1 site in Ghana. Open to participants aged 2 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by University of California, Davis · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 2,372
Allocation: Randomized
Ages: 2 Years to 49 Years
Sex: All

Study 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 (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.

Conditions studied

Vitamin A Deficiency
Iron-deficiency
Folate Deficiency
Vitamin B 12 Deficiency
Zinc Deficiency
Anemia

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Keywords

Micronutrient, Food Fortification,

In context

Vitamin A Deficiency

72 studies on the registry are indexed under Vitamin A Deficiency; 8 are open to participants now.

This study's enrollment of 2,372 is above the median of 168 across 54 interventional studies indexed under Vitamin A Deficiency.

Browse Vitamin A Deficiency studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 145 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 49 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion/exclusion criteria at recruitment (home visit):

Household

Inclusion criteria:

- 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.

Exclusion criteria:

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

Inclusion criteria:

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;
Not planning to become pregnant during the next 10 months.

Exclusion criteria:

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.

Children 2-5 years of age (24-59 mo)

Inclusion criteria:

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.

Exclusion criteria:

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

Inclusion criteria:

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.

Exclusion criteria:

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].

Exclusion criteria at baseline visit:

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.

Exclusion criteria during course of the intervention:

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).

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 2,372 participants (actual)

Study arms

Experimental
Multiple micronutrient-fortified bouillon cube
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).
Dietary Supplement: Multiple micronutrient-fortified bouillon cube
Placebo comparator
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).
Dietary Supplement: Control bouillon cube (iodine-only)

Interventions

Dietary supplementMultiple micronutrient-fortified bouillon cube
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)
Dietary supplementControl bouillon cube (iodine-only)
Bouillon cube fortified with 30 µg/g Iodine (KIO3)

What researchers measure

Primary outcomes

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
Time frame: 38 weeks
Change in vitamin A status among children 2-5 years
Plasma retinol-binding protein (RBP) concentrations, measured at baseline and endline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 38 weeks
Change in hemoglobin concentration among non-pregnant, non-lactating women
Hemoglobin concentration measured in venous blood at baseline and endline
Time frame: 38 weeks
Change in hemoglobin concentration among children 2-5 years
Hemoglobin concentration measured in venous blood at baseline and endline
Time frame: 38 weeks
Change in zinc status among non-pregnant, non-lactating women
Plasma zinc measured at baseline and endline
Time frame: 38 weeks
Change in zinc status among children 2-5 years
Plasma zinc measured at baseline and endline
Time frame: 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
Time frame: 38 weeks
Change in folate status among children 2-5 years
Plasma folate concentrations, measured at baseline and endline
Time frame: 38 weeks
Change in vitamin B12 status among non-pregnant, non-lactating women
Plasma vitamin B12 concentrations, measured at baseline and endline
Time frame: 38 weeks
Change in vitamin B12 status among children 2-5 years
Plasma vitamin B12 concentrations, measured at baseline and endline
Time frame: 38 weeks
Change in vitamin B12 status among lactating women 4-18 months postpartum
Breast milk vitamin B12 concentrations, measured at baseline and endline
Time frame: 12 weeks

Secondary outcomes

Average daily household consumption of bouillon
Assessed biweekly by questionnaire, observed stocks, and wrapper counts.
Time frame: 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
Time frame: 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
Time frame: 38 weeks
Change in serum folate concentration among non-pregnant, non-lactating women
Serum folate concentration, measured at baseline and endline
Time frame: 38 weeks
Change in plasma retinol concentration among children 2-5 years
Measured at baseline and endline
Time frame: 38 weeks
Change in iodine status among non-pregnant, non-lactating women
Urinary iodine concentration, measured at baseline and endline
Time frame: 38 weeks
Change in iodine status among children 2-5 years
Urinary iodine concentration, measured at baseline and endline
Time frame: 38 weeks
Change in iodine status among lactating women 4-18 months postpartum
Urinary iodine concentration, measured at baseline and endline
Time frame: 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
Time frame: 38 weeks
Change in inflammation among non-pregnant, non-lactating women
Plasma concentrations of acute phase proteins, measured at baseline and endline
Time frame: 38 weeks
Change in inflammation among children 2-5 years
Plasma concentrations of acute phase proteins, measured at baseline and endline
Time frame: 38 weeks
Change in current or recent malaria among non-pregnant, non-lactating women
Assessed by rapid diagnostic test at baseline and endline
Time frame: 38 weeks
Change in current or recent malaria among children 2-5 years
Assessed by rapid diagnostic test at baseline and endline
Time frame: 38 weeks
Morbidity among non-pregnant, non-lactating women
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Time frame: 38 weeks
Morbidity among children 2-5 years
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Time frame: 38 weeks
Morbidity among lactating women 4-18 months postpartum
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 weeks
Change in anemia among non-pregnant, non-lactating women
Hemoglobin concentrations \< 12 g/dL, measured at baseline and endline
Time frame: 38 weeks
Change in anemia among children 2-5 years
Hemoglobin concentrations \< 11 g/dL, measured at baseline and endline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Systolic and diastolic blood pressure among non-pregnant, non-lactating women
Assessed by portable device
Time frame: 38 weeks
Hypertension among non-pregnant, non-lactating women
Based on blood pressure measured by portable device
Time frame: 38 weeks
Change in faecal calprotectin concentrations among children 2-5 years
Stool samples collected at baseline and endline
Time frame: 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
Time frame: 38 weeks
Change in weight-for-height Z score and wasting (WHZ < -2) among children 2-5 years
Standardized using WHO child growth standards
Time frame: 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)
Time frame: 38 weeks
Fecal microbiota among children 2-5 years
Stool samples collected at baseline and endline
Time frame: 38 weeks
Change in cognitive development among children 2-5 years
Early Years Toolbox scores at baseline and endline
Time frame: 38 weeks

Other outcomes

Household food security
Assessed monthly using the Household Food Insecurity and Access Scale (HFIAS)
Time frame: 38 weeks
Household water security
Assessed monthly by the Household Water Insecurity Experience Scale (HWISE)
Time frame: 38 weeks
Change in weight-for-age Z score and underweight (WAZ < -2) among children 2-5 years
Standardized using WHO child growth standards
Time frame: 38 weeks
Change in zinc protoporphyrin (ZPP) concentrations
Measured by portable device
Time frame: 38 weeks

Study locations

1 site

University of Ghana
Accra, Ghana

References and documents

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 41931601 ↗
Engle-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 ↗

Individual participant data

Plan to share: 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.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Jun 2024, 16 months.

Of 20 interventional studies with no phase under Vitamin A Deficiency, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 16 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 29, 2021
First posted: Jan 5, 2022
StartActual: Jan 16, 2023
Primary completionActual: Jun 10, 2024
CompletionActual: Jun 12, 2024
Last update: Jul 12, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05178407
Lead sponsor: University of California, Davis
Collaborators: University of Ghana, Newcastle University, Penn State University, Helen Keller International
Responsible party: Sponsor
First posted: Jan 5, 2022
Start date: Jan 16, 2023
Primary completion: Jun 10, 2024
Completion: Jun 12, 2024
Last update: Jul 12, 2024

Study contacts

Reina Engle-Stone, PhD

principal investigator · Department of Nutrition, UC Davis

Seth Adu-Afarwuah, PhD

principal investigator · University of Ghana

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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