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

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 intheir household for the next 10 months.

Exclusion criteria:

• Reported chronic medical condition requiring frequent blood transfusion (e.g. severeforms 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 aprevious adverse reaction to bouillon by the participant or any member of theirhousehold.

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 indexparticipant 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 repeateligibility 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, lossof smell or taste within the past 72 hours) [individual may repeat eligibilityassessment after deferral];

• Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiringfrequent 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 repeateligibility 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, lossof smell or taste within the past 72 hours) [individual may repeat eligibilityassessment after deferral];

• Mid-upper arm circumference < 11.5 cm;

• Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiringfrequent medical attention or potentially interfering with nutritional status.

Lactating women

Inclusion criteria:

• Non-pregnant women of reproductive age (15 - 49 years), currently breastfeeding achild 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 indexparticipant 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 repeateligibility 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, lossof smell or taste within the past 72 hours) [individual may repeat eligibilityassessment after deferral];

• Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiringfrequent 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 repeateligibility 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, lossof smell or taste within the past 72 hours) [individual may repeat eligibilityassessment after deferral];

• Recent diarrhea [≥3 liquid or semiliquid stools in 72 hours]) [individual may repeateligibility 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 gonadotropinon the day of isotope dosing);

• Incomplete consumption of vitamin A isotope dose;

• Positive malaria RDT on the day of isotope dosing [individual may repeat eligibilityassessment after deferral];

• CRP > 5 mg/L on the day of isotope dosing [individual may repeat eligibilityassessment 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 repeateligibility 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, lossof smell or taste within the past 72 hours) [individual may repeat eligibilityassessment 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 repeateligibility 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, lossof smell or taste within the past 72 hours) [individual may repeat eligibilityassessment after referral];

• Severe acute malnutrition at baseline (weight-for-height Z-score < -3 SD orbilateral oedema).

Lactating women

• Severe illness warranting immediate hospital referral;

• COVID-19 diagnosis or exposure in the previous two weeks [individual may repeateligibility 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, orloss of taste or smell within the past 72 hours) [individual may repeat eligibilityassessment after deferral];

• Pregnancy (determined by self-report);

• Cessation of lactation, or planning to discontinue breastfeeding in the next threemonths.

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 gonadotropinat pre-endline isotope dosing).

Lactating women

• Cessation of lactation (determined by self-report);

• Pregnancy (determined by self-report).