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

• Conditions: Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202206868437931
• Lead Sponsor: niversity of California Davis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 2408

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in vitamin A status among non-pregnant, non-lactating women;Change in vitamin A status among children 2-5 years;Change in vitamin A status among lactating women 4-18 mo postpartum;Change in iron status among non-pregnant, non-lactating women;Change in iron status among children 2-5 years;Change in hemoglobin concentration among non-pregnant, non-lactating women;Change in hemoglobin concentration among children 2-5 years;Change in zinc status among non-pregnant, non-lactating women;Change in zinc status among children 2-5 years;Change in folate status among non-pregnant, non-lactating women;Change in folate status among children 2-5 years;Change in vitamin B12 status among non-pregnant, non-lactating women;Change in vitamin B12 status among children 2-5 years;Change in vitamin B12 status among lactating women 4-18 months postpartum