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

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Multiple 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_SUPPLEMENT

Control bouillon cube (iodine-only)

Bouillon cube fortified with 30 µg/g Iodine (KIO3)

Sponsors & Collaborators

• University of California, Davis

  lead OTHER

• University of Ghana

  collaborator OTHER

• Newcastle University

  collaborator OTHER

• Penn State University

  collaborator OTHER

• Helen Keller International

  collaborator OTHER

Principal Investigators

• Reina Engle-Stone, PhD · Department of Nutrition, UC Davis

• Seth Adu-Afarwuah, PhD · University of Ghana

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-16

Primary Completion

2024-06-10

Completion

2024-06-12

Countries

• Ghana

Study Locations