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

NCT05178407 | Completed DMC

• 1 other identifier: 1837253
• Study Type: interventional
• Target: 2,372
• Locations: 1 country
• Sites: 1

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. 1.Micronutrient status among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
2. 2.Hemoglobin concentrations among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
3. 3.Breast milk micronutrient concentrations among lactating women 4-18 months postpartum after 3 months of intervention
4. 4.a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or
5. 5.a control cube containing iodine only

Conditions

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

Keywords

Micronutrient, Food Fortification,

Outcome Measures

Primary Outcomes (14)

• 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

  38 weeks

• Change in vitamin A status among children 2-5 years

  Plasma retinol-binding protein (RBP) concentrations, measured at baseline and endline

  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

  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

  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

  38 weeks

• Change in hemoglobin concentration among non-pregnant, non-lactating women

  Hemoglobin concentration measured in venous blood at baseline and endline

  38 weeks

• Change in hemoglobin concentration among children 2-5 years

  Hemoglobin concentration measured in venous blood at baseline and endline

  38 weeks

• Change in zinc status among non-pregnant, non-lactating women

  Plasma zinc measured at baseline and endline

  38 weeks

• Change in zinc status among children 2-5 years

  Plasma zinc measured at baseline and endline

  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

  38 weeks

• Change in folate status among children 2-5 years

  Plasma folate concentrations, measured at baseline and endline

  38 weeks

• Change in vitamin B12 status among non-pregnant, non-lactating women

  Plasma vitamin B12 concentrations, measured at baseline and endline

  38 weeks

• Change in vitamin B12 status among children 2-5 years

  Plasma vitamin B12 concentrations, measured at baseline and endline

  38 weeks

• Change in vitamin B12 status among lactating women 4-18 months postpartum

  Breast milk vitamin B12 concentrations, measured at baseline and endline

  12 weeks

Secondary Outcomes (32)

• Average daily household consumption of bouillon

  38 weeks

• Adherence to study-provided bouillon

  38 weeks

• Change in vitamin A status markers among non-pregnant, non-lactating women

  38 weeks

• Change in serum folate concentration among non-pregnant, non-lactating women

  38 weeks

• Change in plasma retinol concentration among children 2-5 years

  38 weeks

Other Outcomes (4)

• Household food security

  38 weeks

• Household water security

  38 weeks

• Change in weight-for-age Z score and underweight (WAZ < -2) among children 2-5 years

  38 weeks

Study Arms (2)

Multiple micronutrient-fortified bouillon cube

EXPERIMENTAL

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).

Dietary Supplement: Multiple micronutrient-fortified bouillon cube

Control bouillon cube (iodine only)

PLACEBO COMPARATOR

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).

Dietary Supplement: Control bouillon cube (iodine-only)

Interventions

Multiple micronutrient-fortified bouillon cube DIETARY_SUPPLEMENT

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)

Multiple micronutrient-fortified bouillon cube

Control bouillon cube (iodine-only) DIETARY_SUPPLEMENT

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

Control bouillon cube (iodine only)

Eligibility Criteria

• Age: 2 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Household
• \- 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.
• Reported chronic medical condition requiring frequent blood transfusion (e.g. severe forms 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 a previous adverse reaction to bouillon by the participant or any member of their household.
• Non-pregnant, non-lactating women of reproductive age
• 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 index participant 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.
• Severe illness warranting immediate hospital referral;
• COVID-19 diagnosis or exposure in the previous two weeks \[individual may repeat eligibility assessment after deferral\];
• Presence of morbidity symptoms suggesting COVID-19 infection (fever \[temperature \> 38°C\], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) \[individual may repeat eligibility assessment after deferral\];
• Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status;

Sponsors & Collaborators

• University of California, Davis: lead
• University of Ghana: collaborator
• Newcastle University: collaborator
• Penn State University: collaborator
• Helen Keller International: collaborator

Study Sites (1)

University of Ghana

Accra, Ghana

Location

Related Publications (1)

• Engle-Stone R, Wessells KR, Haskell MJ, Kumordzie SM, Arnold CD, Davis JN, Becher ER, Fuseini AD, Nyaaba KW, Tan X, Adams KP, Lietz G, Vosti SA, Adu-Afarwuah S. Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial. PLoS One. 2024 May 6;19(5):e0302968. doi: 10.1371/journal.pone.0302968. eCollection 2024.

  PMID: 38709803 DERIVED

MeSH Terms

Conditions

Vitamin A Deficiency; Anemia, Iron-Deficiency; Folic Acid Deficiency; Vitamin B 12 Deficiency; Anemia

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Vitamin B Deficiency

Study Officials

• Reina Engle-Stone, PhD

  Department of Nutrition, UC Davis

  PRINCIPAL INVESTIGATOR

• Seth Adu-Afarwuah, PhD

  University of Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 5, 2022
• Study Start: January 16, 2023
• Primary Completion: June 10, 2024
• Study Completion: June 12, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

GH (1)