Anemia, Folate Deficiency, Iron-deficiency, Vitamin A Deficiency, Vitamin B 12 Deficiency, Zinc Deficiency
Conditions
Keywords
Micronutrient, Food Fortification,
Brief 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: 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.
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)
Sponsors
University of Ghana
Newcastle University
Penn State University
Helen Keller International
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The two study groups will receive different bouillon formulations in packaging that is identical except for the study group code. Linkage between the study group codes and bouillon formulations will be known only to the bouillon producer and independent codekeepers, and not to the investigators, data collection staff, or participants.
Eligibility
Sex/Gender
ALL
Age
2 Years to 49 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vitamin B12 status among children 2-5 years | 38 weeks | Plasma vitamin B12 concentrations, measured at baseline and endline |
| Change in vitamin B12 status among lactating women 4-18 months postpartum | 12 weeks | Breast milk vitamin B12 concentrations, measured at baseline and endline |
| Change in vitamin A status among non-pregnant, non-lactating women | 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 | 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 | 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 | 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 | 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 | 38 weeks | Hemoglobin concentration measured in venous blood at baseline and endline |
| Change in hemoglobin concentration among children 2-5 years | 38 weeks | Hemoglobin concentration measured in venous blood at baseline and endline |
| Change in zinc status among non-pregnant, non-lactating women | 38 weeks | Plasma zinc measured at baseline and endline |
| Change in zinc status among children 2-5 years | 38 weeks | Plasma zinc measured at baseline and endline |
| Change in folate status among non-pregnant, non-lactating women | 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 | 38 weeks | Plasma folate concentrations, measured at baseline and endline |
| Change in vitamin B12 status among non-pregnant, non-lactating women | 38 weeks | Plasma vitamin B12 concentrations, measured at baseline and endline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbiota among children 2-5 years | 38 weeks | Stool samples collected at baseline and endline |
| Change in faecal calprotectin concentrations among children 2-5 years | 38 weeks | Stool samples collected at baseline and endline |
| Change in height-for-age Z score and stunting (HAZ < -2) among children 2-5 years | 38 weeks | Standing height, standardized using WHO child growth standards |
| Change in weight-for-height Z score and wasting (WHZ < -2) among children 2-5 years | 38 weeks | Standardized using WHO child growth standards |
| Change in cognitive development among children 2-5 years | 38 weeks | Malawi Developmental Assessment Tool (MDAT) scores in 4 domains (gross motor, fine motor, language, social) |
| Average daily household consumption of bouillon | 38 weeks | Assessed biweekly by questionnaire, observed stocks, and wrapper counts. |
| Adherence to study-provided bouillon | 38 weeks | 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 |
| Change in vitamin A status markers among non-pregnant, non-lactating women | 38 weeks | Plasma or serum retinol and retinol-binding protein (RBP) concentrations, measured at baseline and endline |
| Change in serum folate concentration among non-pregnant, non-lactating women | 38 weeks | Serum folate concentration, measured at baseline and endline |
| Change in plasma retinol concentration among children 2-5 years | 38 weeks | Measured at baseline and endline |
| Change in iodine status among non-pregnant, non-lactating women | 38 weeks | Urinary iodine concentration, measured at baseline and endline |
| Change in iodine status among children 2-5 years | 38 weeks | Urinary iodine concentration, measured at baseline and endline |
| Change in iodine status among lactating women 4-18 months postpartum | 12 weeks | Urinary iodine concentration, measured at baseline and endline |
| Change in urinary sodium concentrations among non-pregnant, non-lactating women | 38 weeks | Urinary sodium concentration, expressed as sodium:potassium ratio, measured at baseline and endline |
| Change in inflammation among non-pregnant, non-lactating women | 38 weeks | Plasma concentrations of acute phase proteins, measured at baseline and endline |
| Change in inflammation among children 2-5 years | 38 weeks | Plasma concentrations of acute phase proteins, measured at baseline and endline |
| Change in current or recent malaria among non-pregnant, non-lactating women | 38 weeks | Assessed by rapid diagnostic test at baseline and endline |
| Change in current or recent malaria among children 2-5 years | 38 weeks | Assessed by rapid diagnostic test at baseline and endline |
| Morbidity among non-pregnant, non-lactating women | 38 weeks | Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly |
| Morbidity among children 2-5 years | 38 weeks | Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly |
| Morbidity among lactating women 4-18 months postpartum | 12 weeks | Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly |
| Change in dietary intake among non-pregnant, non-lactating women | 38 weeks | Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline and endline |
| Change in dietary intake among children 2-5 years | 38 weeks | Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline and endline |
| Dietary intake among lactating women 4-18 months postpartum | 4 weeks | Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline |
| Change in anemia among non-pregnant, non-lactating women | 38 weeks | Hemoglobin concentrations \< 12 g/dL, measured at baseline and endline |
| Change in anemia among children 2-5 years | 38 weeks | Hemoglobin concentrations \< 11 g/dL, measured at baseline and endline |
| Change in micronutrient deficiency among non-pregnant, non-lactating women | 38 weeks | Based on biomarkers of micronutrient status (vitamin A, iron, zinc, folate, vitamin B12), measured at baseline and endline |
| Change in micronutrient deficiency among children 2-5 years | 38 weeks | Based on biomarkers of micronutrient status (vitamin A, iron, zinc, folate, vitamin B12), measured at baseline and endline |
| Change in low milk nutrient concentrations among lactating women 4-18 months postpartum | 12 weeks | Based on concentrations of vitamin A and vitamin B12, measured at baseline and endline |
| Systolic and diastolic blood pressure among non-pregnant, non-lactating women | 38 weeks | Assessed by portable device |
| Hypertension among non-pregnant, non-lactating women | 38 weeks | Based on blood pressure measured by portable device |
Other
| Measure | Time frame | Description |
|---|---|---|
| Household water security | 38 weeks | Assessed monthly by the Household Water Insecurity Experience Scale (HWISE) |
| Change in weight-for-age Z score and underweight (WAZ < -2) among children 2-5 years | 38 weeks | Standardized using WHO child growth standards |
| Change in zinc protoporphyrin (ZPP) concentrations | 38 weeks | Measured by portable device |
| Household food security | 38 weeks | Assessed monthly using the Household Food Insecurity and Access Scale (HFIAS) |
Countries
Ghana
Outcome results
None listed