Acceptability of Fortified Bouillon Cubes in Northern Ghana

NCT ID: NCT05177614

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2022-01-28

Brief Summary

This study aims to evaluate the acceptability of bouillon cubes fortified with six micronutrients for which deficiency is common among women and children in Ghana and to assess the feasibility and reliability of data collection methods to be used in a planned, more detailed study to evaluate the effect of multiple micronutrient (MN)-fortified bouillon cube on biomarkers of nutrient status, health and development of women and children.

Detailed Description

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 many 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, acceptable and effective for preventing micronutrient deficiencies in communities where such deficiencies are common.

Objectives: This study aims (1) to evaluate the acceptability of bouillon cubes formulated with 6 micronutrients for which deficiency is common among women and children in Ghana and (2) to access the feasibility and reliability of data collection methods to be used in a later study of the effects of fortified bouillon, compared to control, on micronutrient status, health, and development.

Methods: This acceptability study will be conducted in the Kumbungu and Tolon districts in the Northern Region, where a recent survey showed that micronutrient deficiencies were common. The investigators will recruit non-pregnant adult women (15+ years old) (n = 84) who are responsible for household meal preparation, to participate in sensory testing of an uncooked fortified bouillon as well as a cooked food containing the fortified bouillon. Subsequently, participants will receive a 14-day supply of fortified bouillon cubes to use at home, after which they will be asked their opinions about the bouillon. Three fortified bouillon formulations will be tested: 1) upper-level bouillon, fortified with iron, zinc, iodine, vitamin A, folic acid, and vitamin B-12, 2) lower-level bouillon, containing the same 6 micronutrients but with lower concentrations of some micronutrients, and 3) a control bouillon, fortified with iodine only. Participants will be in the study for approximately 18 days (study day 0 to study day 17). In addition, children 2-6 years of age in households of enrolled women will be eligible to participate in a pilot study to evaluate the feasibility and test-retest reliability of several methods to assess child development. For these children, child development will be assessed at two home visits during the 14-day period of fortified bouillon use at home.

Conditions

Food, Fortified; Dietary Habits; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Upper-level multiple micronutrient-fortified bouillon cube

10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients

Group Type: EXPERIMENTAL

Upper-level multiple micronutrient-fortified bouillon cube

Intervention Type: DIETARY_SUPPLEMENT

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)

Lower-level multiple micronutrient-fortified bouillon cube

10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients

Group Type: EXPERIMENTAL

Lower-level multiple micronutrient-fortified bouillon cube

Intervention Type: DIETARY_SUPPLEMENT

28.8 µg/g Folic acid 0.288 µg/g Vitamin B12 1.68 mg/g Zinc (ZnO) 1.3 mg/g Iron (FePP/citric acid/trisodium citrate) 96 µg/g Vitamin A (retinyl palmitate) 30 µg/g Iodine (KIO3)

Control (iodine-fortified bouillon cube)

10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with one micronutrient

Group Type: PLACEBO_COMPARATOR

Iodine-fortified bouillon cube

Intervention Type: DIETARY_SUPPLEMENT

30 µg/g Iodine (KIO3)

Interventions

Upper-level multiple micronutrient-fortified bouillon cube

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)

Intervention Type: DIETARY_SUPPLEMENT

Lower-level multiple micronutrient-fortified bouillon cube

28.8 µg/g Folic acid 0.288 µg/g Vitamin B12 1.68 mg/g Zinc (ZnO) 1.3 mg/g Iron (FePP/citric acid/trisodium citrate) 96 µg/g Vitamin A (retinyl palmitate) 30 µg/g Iodine (KIO3)

Intervention Type: DIETARY_SUPPLEMENT

Iodine-fortified bouillon cube

30 µg/g Iodine (KIO3)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Acceptability study:

• self-reported non-pregnant adult women (15+ years)
• responsible for meal preparation in the household
• signed the informed consent form

Child development assessment pilot sub-study:

• 2-6 years of age (24-71 months)
• residing in the same household as an enrolled woman
• child's primary caregiver signs the informed consent form

Exclusion Criteria

• severe illness warranting immediate hospital referral
• COVID-19 exposure, positive test, or current symptoms (including fever, cough, shortness of breath, loss of smell, vomiting, or diarrhea [> 3 liquid or semi-liquid stools in 24h]) of illness
• chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status or affecting child development (children only)
• presence of ailments (such as toothache, or mouth pain) that may impact a participant's ability to complete study activities (women only)
• unable to provide informed consent due to impaired decision making abilities
• current participation in a clinical trial
• reported shrimp, wheat, milk, soy, eggs, celery, fish, or mollusc allergy, or a previous adverse reaction to bouillon by anyone in the household
• refusal to use provided bouillon cubes to prepare household meals while enrolled in the study

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ghana

OTHER

Sponsor Role: collaborator

Helen Keller International

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Reina Engle-Stone, Ph.D

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reina Engle-Stone, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Seth Adu-Afarwuah, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ghana

Locations

University of Ghana

Accra, , Ghana

Countries

Ghana

References

Wessells KR, Kumordzie SM, Becher E, Davis JN, Nyaaba KW, Zyba SJ, Arnold CD, Tan X, Vosti SA, Adams KP, Haskell M, Adu-Afarwuah S, Engle-Stone R. Acceptability of Multiple Micronutrient-Fortified Bouillon Cubes among Women and Their Households in 2 Districts in The Northern Region of Ghana. Curr Dev Nutr. 2023 Dec 8;8(1):102056. doi: 10.1016/j.cdnut.2023.102056. eCollection 2024 Jan.

Reference Type: DERIVED

PMID: 38304733 (View on PubMed)

Other Identifiers

017/12/20

Identifier Type: OTHER

Identifier Source: secondary_id

1687671

Identifier Type: -

Identifier Source: org_study_id