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

Not Applicable

Completed

• Conditions: Iron-deficiency; Folate Deficiency; Vitamin B 12 Deficiency; Zinc Deficiency; Vitamin A Deficiency; Anemia
• Interventions: Dietary Supplement: Multiple micronutrient-fortified bouillon cube; Dietary Supplement: Control bouillon cube (iodine-only)

• Registration Number: NCT05178407
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2022-01-05
• Study Start: 2023-01-16
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2372

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple micronutrient-fortified bouillon cube	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).
Control bouillon cube (iodine only)	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).

Primary Outcome Measures

Name	Time	Method
Change in zinc status among children 2-5 years	38 weeks	Plasma zinc measured 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 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 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 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 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 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 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 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
Change in vitamin B12 status among children 2-5 years	38 weeks	Plasma vitamin B12 concentrations, measured at baseline and endline

Secondary Outcome Measures

Name	Time	Method
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
Morbidity among children 2-5 years	38 weeks	Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
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
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 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 current or recent malaria among non-pregnant, non-lactating women	38 weeks	Assessed by rapid diagnostic test 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 children 2-5 years	38 weeks	Assessed by rapid diagnostic test at baseline and endline
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
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 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 faecal calprotectin concentrations among children 2-5 years	38 weeks	Stool samples collected at baseline and endline
Change in weight-for-height Z score and wasting (WHZ < -2) among children 2-5 years	38 weeks	Standardized using WHO child growth standards
Morbidity among non-pregnant, non-lactating women	38 weeks	Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
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 iodine status among non-pregnant, non-lactating women	38 weeks	Urinary iodine concentration, 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 anemia among children 2-5 years	38 weeks	Hemoglobin concentrations \< 11 g/dL, measured at baseline and endline
Systolic and diastolic blood pressure among non-pregnant, non-lactating women	38 weeks	Assessed by portable device
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 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
Hypertension among non-pregnant, non-lactating women	38 weeks	Based on blood pressure measured by portable device
Change in cognitive development among children 2-5 years	38 weeks	Early Years Toolbox scores at baseline and endline
Fecal microbiota among children 2-5 years	38 weeks	Stool samples collected at baseline and endline

Trial Locations

Locations (1)

University of Ghana; 🇬🇭 Accra, Ghana