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: 1. Micronutrient status among women 15-49 years of age and children 2-5 years of age after 9 months of intervention 2. Hemoglobin concentrations among women 15-49 years of age and children 2-5 years of age after 9 months of intervention 3. 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: 1. a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or 2. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
2,372
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)
Bouillon cube fortified with 30 µg/g Iodine (KIO3)
University of Ghana
Accra, Ghana
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
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
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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