Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206868437931 Date of Approval: 23/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 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
Official scientific title 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
Brief summary describing the background and objectives of the trial 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
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 31/12/2022
Actual trial start date 16/01/2023
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 2408
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
NCT05178407 clinicaltrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control bouillon cube 10-gram bouillon cube fortified with 30 µg/g Iodine (KIO3). 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. 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) 10-gram, shrimp-flavoured bouillon cube fortified with 30 µg/g Iodine (KIO3). 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). 1204 Placebo
Experimental Group Multiple micronutrient fortified bouillon cube 10-gram 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). 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. 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) 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). 1204
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Head of household provides oral consent for participation of household members (index participants), and willingness to have study-provided bouillon used in household cooking for the next 10 months. 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. Child 2-5 years of age (24-59 mo); Signed informed consent for the child's participation from a parent or guardian; Planning to remain in the study area for the next 10 months; Caregiver willing to use study-provided bouillon in household cooking for the next 10 months. Lactating women: Non-pregnant women of reproductive age (15 - 49 years), currently breastfeeding a child who is 4-18 months of age; Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, provide assent from the index participant and consent from a parent or guardian); Planning to remain in the study area for the next 4 months; Planning to breastfeed for the next 4 months; Willing to use study-provided bouillon in household cooking for the next 4 months; Not planning to become pregnant during the next 4 months. Exclusion criteria at recruitment visit: 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; Reported chronic medical condition requiring frequent blood transfusion (e.g. severe forms of thalassemia) among any household members; Unable to provide informed consent due to impaired decision-making abilities (women only); 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. Mid-upper arm circumference <11.5cm (children 2-5 years only) Pregnancy (determined by self-report)(lactating women only, at recruitment) Note: Field is not large enough to include all exclusion criteria at all time points. Please see clinicaltrials.gov NCT05178407 for complete list. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Year(s) 49 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/07/2022 Food and Drugs Authority Ghana
Ethics Committee Address
Street address City Postal code Country
PO Box CT 2783 Cantonments-Accra n/a Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/04/2022 Ghana Health Services Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
PO Box MB 190 Accra n/a Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/09/2022 UC Davis Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2921 Stockton Blvd Suite 1400, Room 1429 Sacramento 95817 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in vitamin A status among non-pregnant, non-lactating women 38 weeks
Primary Outcome Change in vitamin A status among children 2-5 years 38 weeks
Primary Outcome Change in vitamin A status among lactating women 4-18 mo postpartum 12 weeks
Primary Outcome Change in iron status among non-pregnant, non-lactating women 38 weeks
Primary Outcome Change in iron status among children 2-5 years 38 weeks
Primary Outcome Change in hemoglobin concentration among non-pregnant, non-lactating women 38 weeks
Primary Outcome Change in hemoglobin concentration among children 2-5 years 38 weeks
Primary Outcome Change in zinc status among non-pregnant, non-lactating women 38 weeks
Primary Outcome Change in zinc status among children 2-5 years 38 weeks
Primary Outcome Change in folate status among non-pregnant, non-lactating women 38 weeks
Primary Outcome Change in folate status among children 2-5 years 38 weeks
Primary Outcome Change in vitamin B12 status among non-pregnant, non-lactating women 38 weeks
Primary Outcome Change in vitamin B12 status among children 2-5 years 38 weeks
Primary Outcome Change in vitamin B12 status among lactating women 4-18 months postpartum 12 weeks
Secondary Outcome Average daily household consumption of bouillon 38 weeks
Secondary Outcome Adherence to study-provided bouillon 38 weeks
Secondary Outcome Change in vitamin A status markers among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in serum folate concentration among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in plasma retinol concentration among children 2-5 years 38 weeks
Secondary Outcome Change in iodine status among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in iodine status among children 2-5 years 38 weeks
Secondary Outcome Change in iodine status among lactating women 4-18 months postpartum 12 weeks
Secondary Outcome Change in urinary sodium concentrations among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in inflammation among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in inflammation among children 2-5 years 38 weeks
Secondary Outcome Change in current or recent malaria among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in current or recent malaria among children 2-5 years 38 weeks
Secondary Outcome Morbidity among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Morbidity among children 2-5 years 38 weeks
Secondary Outcome Morbidity among lactating women 4-18 months postpartum 12 weeks
Secondary Outcome Change in dietary intake among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in dietary intake among children 2-5 years 38 weeks
Secondary Outcome Dietary intake among lactating women 4-18 months postpartum 12 weeks
Secondary Outcome Change in anemia among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in anemia among children 2-5 years 38 weeks
Secondary Outcome Change in micronutrient deficiency among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in micronutrient deficiency among children 2-5 years 38 weeks
Secondary Outcome Change in low milk nutrient concentrations among lactating women 4-18 months postpartum 12 weeks
Secondary Outcome Systolic and diastolic blood pressure among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Hypertension among non-pregnant, non-lactating women 38 weeks
Secondary Outcome Change in faecal calprotectin concentrations among children 2-5 years 38 weeks
Secondary Outcome Change in height-for-age Z score and stunting (HAZ < -2) among children 2-5 years 38 weeks
Secondary Outcome Change in weight-for-height Z score and wasting (WHZ < -2) among children 2-5 years 38 weeks
Secondary Outcome Change in cognitive development among children 2-5 years 38 weeks
Secondary Outcome Fecal microbiota among children 2-5 years, measured at baseline and endline 38 weeks
Secondary Outcome Change in cognitive development among children 2-5 years, assessed by Early Years Toolbox scores at baseline and endline 38 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
District Health Directorate Unnamed Road Tolon Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Helen Keller International Rue Lib11 Dakar Senegal
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of California Davis One Shields Ave Davis United States of America University
COLLABORATORS
Name Street address City Postal code Country
University of Ghana Legon Accra Ghana
Newcastle University Framlington Place Newcastle upon Tyne United Kingdom
The Pennsylvania State University 201 Old Main University Park United States of America
Helen Keller International Rue LIB 11 Dakar Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reina EngleStone renglestone@ucdavis.edu +15307523827 One Shields Ave
City Postal code Country Position/Affiliation
Davis 95616 United States of America Department of Nutrition
Role Name Email Phone Street address
Principal Investigator Seth Adu Afarwuah sadu-afarwuah@ug.edu.gh +233249149385 Legon
City Postal code Country Position/Affiliation
Accra Ghana Department of Nutrition and Food Science
Role Name Email Phone Street address
Scientific Enquiries K Ryan Wessells krwessells@ucdavis.edu +15307521992 One Shields Ave
City Postal code Country Position/Affiliation
Davis United States of America Department of Nutrition
Role Name Email Phone Street address
Public Enquiries Seth Adu Afarwuah sadu-afarwuah@ug.edu.gh +233249149385 Legon
City Postal code Country Position/Affiliation
Accra Ghana Department of Nutrition and Food Science University of Ghana
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The investigators will commit to Global Access. The investigators intend to 1) publish journal articles describing the study results with an Open Access license, 2) make available information about study methods, such as protocols or standard operating procedures, on the study website, and 3) make available de-identified datasets upon request by the study sponsor or other investigators. Material/DataTransfer Agreements will be developed between study collaborators, sponsor, and any organizations that may request the data; terms of the agreement will be subject to the data handling and storage procedures approved by the University of California, Davis Institutional Review Board (IRB) and Ghana Health Services Ethical Review Committee (GHS-ERC). Informed Consent Form,Statistical Analysis Plan,Study Protocol Undecided Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information