Iron DeficiencyNCT04632771

Nutritional Status and Bouillon Use in Northern Ghana

An observational study of Iron Deficiency and Vitamin A Deficiency, run by University of California, Davis at 1 site in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for: Iron Deficiency, Vitamin A Deficiency, Vitamin B 12 Deficiency
What is being tested?: N/A (observational study)
How many people: 995 participants
Where: 1 siteGhana
Study dates: 19 Oct 2020to 28 Feb 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Households in the urban and rural areas in Tolon and Kumbungu districts, in northern Ghana

Who may be able to join

non-pregnant, non-lactating woman of reproductive age (15-49 years) OR child 2-5 years of age OR non-pregnant lactating woman (4-18 mo post-partum, 15-49 years of age)
signed informed consent by participant (if adult woman) or by at least one parent or guardian (if child)
non-pregnant, nonlactating woman of reproductive age (15-49 years)
signed informed consent
planning to remain in the study area for the next 1 month
not planning to become pregnant during the next 1 month

Show all 12Show fewer

non-pregnant, nonlactating woman of reproductive age (15-49 years)
signed informed consent
planning to remain in the study area for the next 4 months
not planning to become pregnant during the next 4 months
Adults (including women, men, and other key community members such as merchants, etc.)
Provision of written informed consent

Who cannot join

severe illness warranting hospital referral
chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially inferring with nutritional status
unable to provide informed consent due to impaired decision making abilities (if adult woman, or caretaker of potentially eligible child)
current participation in a clinical trial
RID Pilot 1
unable to provide informed consent due to impaired decision making abilities

Show all 25Show fewer

pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin)
severe illness warranting hospital referral
reported fever, vomiting or diarrhea (> 3 liquid or semi-liquid stools in 24h) in 7 d prior to data collection
chronic medical condition (e.g. malignancy, gastrointestinal disease) or congenital anomalies requiring frequent medical attention or potentially inferring with nutritional status
current participation in a clinical trial
hemoglobin concentration <80 g/L on the day of isotope dosing
C-reactive protein concentration > 5 mg/L on the day of isotope dosing
reported use of micronutrient supplements that contain vitamin A more than 1 time/wk in the past 30 days
RID Pilot 2
unable to provide informed consent due to impaired decision making abilities
pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin)
severe illness warranting hospital referral
reported fever, vomiting or diarrhea (> 3 liquid or semi-liquid stools in 24h) in 7 d prior to data collection
chronic medical condition (e.g. malignancy, gastrointestinal disease) or congenital anomalies requiring frequent medical attention or potentially inferring with nutritional status
current participation in a clinical trial
hemoglobin concentration <80 g/L on the day of isotope dosing
C-reactive protein concentration > 5 mg/L on the day of isotope dosing
reported use of micronutrient supplements that contain vitamin A more than 1 time/wk in the past 30 days
Formative Research

Trial locations and contacts

1 site in 1 country.

Ghana1 site

University of Ghana
Accra

Other trials in Ghana

About this study

Official title: A Pilot Study to Evaluate the Nutritional Status of Women and Children in Northern Ghana, and Knowledge, Attitudes and Practices Related to Bouillon Cube Use

This pilot aims to generate data that are critical for informing the design of a planned, more detailed study to evaluate the effect of multiple micronutrient (MN)-fortified bouillon cube on biomarkers of nutrient status of women and children. Data collection includes measures of nutritional status and dietary intake among women and children and their households in communities in northern Ghana.

Read the detailed description

Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa including Ghana, which contributes to impaired growth and development in children, increased risk of mortality, and low economic productivity in adults. While large-scale intervention programs (including salt iodization and cooking oil and wheat flour fortification) exist, these programs are often not well-monitored, and they often provide only a subset of nutrients or reach only a subset of the deficient population.

Bouillon cubes may be an ideal fortification vehicle for delivering micronutrients in West Africa because they are purchased by most households (including rural and poorer households), added to home-made meals and consumed by most members of the household in relatively constant amounts, and they are mainly processed centrally at large scale. However, several important questions must be addressed regarding the extent to which multi-fortified bouillon cubes can address inadequate intake of key micronutrients.

Objective: This pilot aims to generate data that are critical for informing the design of a planned, more detailed study to evaluate the effect of multiple micronutrient-fortified bouillon cube on biomarkers of nutrient status of women and children.

Methods: This will be a cross-sectional study, which will be conducted in the Kumbungu and Tolon districts in the Northern Region, where a recent survey showed that micronutrient deficiencies were common. Four sets of research activities will be carried out, including:

Pilot survey: The investigators will recruit non-pregnant, non-lactating women of reproductive age, WRA (n = 250), children 2-5 years of age (n = 250), and lactating women (n= 250) who will be identified from households in selected communities using the random walk method. Information collected will include anthropometric and micronutrient status, hemoglobin concentration, inflammation, morbidity, household-level food consumption, and individual dietary intakes.
Retinol isotope dilution (RID) Pilot Study 1: The investigators will recruit non-pregnant and nonlactating women of reproductive age, WRA (n = 30) from a subset of the same communities as the pilot survey using the random walk method, and quantitatively estimate their total body vitamin A stores after consuming a dose of d6-labelled vitamin A. Total body stores of vitamin A will be estimated at 14 days after dosing.
Retinol isotope dilution (RID) Pilot Study 2 (kinetic study): Based on results from RID pilot study 1, the investigators will recruit non-pregnant and non-lactating women of reproductive age, WRA (n = 123) from a subset of the same communities as the pilot survey using the random walk method, to construct a population-level plasma retinol kinetic curve, after consuming a dose of d6-labelled vitamin A. A compartmental model will be fit to the plasma retinol kinetic data to develop population-specific coefficients for the RID prediction equation to quantitatively estimate total body vitamin A stores of WRA in the study population.
Formative research: The investigators will (a) conduct focus group discussions on knowledge, attitudes and practices related to salt and bouillon cube use, nutrition and health problems in the community, and micronutrient fortification; (b) perform a market assessment of the availability and cost of fortified, non-fortified and potentially fortifiable foods in the communities; and (c) observe how various local food recipes are prepared, including the types and quantities of ingredients used, and cooking duration and temperature.

Conditions: Iron Deficiency, Vitamin A Deficiency, Vitamin B 12 Deficiency, Folate Deficiency, Zinc Deficiency, Dietary Habits
Being tested: N/A (observational study)
Medical subject headings: Iron Deficiencies, Vitamin A Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency, Feeding Behavior, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N/A (observational study)Other
N/A (observational study)

Study groups in NCT04632771
Study group	Role	What they receive
Pilot survey: non-pregnant, non-lactating women		Survey of non-pregnant, non-lactating women 15-49 years of age (n=250) Receives: Other: N/A (observational study)
Pilot survey: lactating women		Survey of lactating women 15-49 years of age who are currently breastfeeding a child 4-18 months of age (n=250) Receives: Other: N/A (observational study)
Pilot survey: children		Survey of children 2-5 years of age (n=250) Receives: Other: N/A (observational study)
RID Pilot 1		Two-week study to assess total body vitamin A stores in a sample of non-pregnant, non-lactating women 15-49 years of age (n=30) Receives: Other: N/A (observational study)
RID Pilot 2		Kinetic study with "Super-woman" design to develop a prediction equation to assess total body vitamin A stores among non-pregnant, non-lactating women 15-49 years of age (n=123) Receives: Other: N/A (observational study)
Focus group discussions		Focus group discussions conducted among women of reproductive age, older women, and men (n=120 total) Receives: Other: N/A (observational study)
Market assessment		Survey of retail outlets selling fortified staple foods and/or bouillon (n=50 shop owners or operators) Receives: Other: N/A (observational study)
Recipe observations		Observations of cooking of local dishes by selected participants (n=50) enrolled in the pilot survey. Receives: Other: N/A (observational study)

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin
Hemoglobin concentration in venous blood (g/dL) among women and children
Measured: Day 1
Iron status
Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children
Measured: Day 1
Vitamin A status
Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children
Measured: Day 1
Vitamin B12 status
Concentrations of vitamin B12 in serum among women and children
Measured: Day 1
Folate status
Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)
Measured: Day 1
Zinc status
Serum zinc concentration among women and children
Measured: Day 1
Breast milk vitamin A concentration
Vitamin A concentration in breast milk, expressed per unit volume and per gram fat
Measured: Day 1
Breast milk vitamin B12 concentration
Vitamin B12 concentration in breast milk
Measured: Day 1
Total body vitamin A stores
Distribution of total body vitamin A stores among non-pregnant, non-lactating women, expressed as total mass and per gram of liver, estimated by retinol isotope dilution
Measured: Day 7
Total body vitamin A stores
Distribution of total body vitamin A stores among non-pregnant, non-lactating women, expressed as total mass and per gram of liver, estimated by retinol isotope dilution
Measured: Day 14
Coefficient "Fa"
Defined as the fraction of the oral tracer dose absorbed and retained in stores, estimated by modeling of data on labeled and unlabelled vitamin A in plasma collected using a "Super Woman" design and used to calculate total body stores for individual participants.
Measured: Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
Coefficient "S"
Defined as retinol specific activity in plasma/stores at time "t", estimated by modeling of data on labeled and unlabelled vitamin A in plasma collected using a "Super Woman" design and used to calculate total body stores for individual participants.
Measured: Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
Prevalence of anemia and micronutrient deficiencies
Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs
Measured: Day 1
Urinary iodine concentration
Iodine concentration of urine among women and children
Measured: Day 1
Themes from focus group discussions
Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues
Measured: Day 1
Recipe ingredients
Quantity of each recipe ingredient (including bouillon and salt) used in common local recipes; interpreted in relation to cooking duration and temperature (type and duration, e.g. of boiling) used in common recipes
Measured: Day 1
Fortified food accessibility
Availability, price, and fortification levels of fortified food products in markets
Measured: Day 1

Secondary outcomes (15)

Blood pressure
Blood pressure measured among women and children (mm Hg, systolic and diastolic)
Measured: Day 1
Hypertension
Prevalence of blood pressure measurements above cutoffs for hypertension
Measured: Day 1
Height, cm
Standing height measured among women and children
Measured: Day 1
Weight, kg
Weight measurement among women and children
Measured: Day 1
Waist to hip ratio
Waist and hip circumference (measured in cm) among women and their ratio
Measured: Day 1
Mid-upper arm circumference, cm
Mid-upper arm circumference measured among children
Measured: Day 1
Anthropometric Z-scores
Z-scores calculated for young children based on WHO growth standards (height-for-age, weight-for-height, height-for-age, BMI-for-age)
Measured: Day 1
Prevalence of undernutrition
Prevalence of anthropometric Z-scores or mid-upper arm circumference below WHO cutoffs to indicate child undernutrition
Measured: Day 1
Prevalence of overweight and obesity
Prevalence of body mass index (women) or BMI-for-age Z-score (children) above WHO cutoffs
Measured: Day 1
Morbidity symptoms
Reported malaria, diarrhea, fever, or vomiting in the past 7 days (all survey participants)
Measured: Day 1
Inflammation
Serum concentrations of CRP, AGP, amyloid A, MCP-1, IL-6, IL-10, IL-1b, adiponectin
Measured: Day 1
Household-food consumption
Calculated daily household level consumption and individual apparent consumption of fortified foods (wheat flour, oil, salt) and bouillon estimated using 1-month recall
Measured: Day 1
Individual dietary intake
Dietary intake of fortified foods and bouillon, measured by 24h recall among a subset of women participating in the survey who also participate in cooking observations
Measured: Day 1
Urinary sodium concentration
Expressed per unit volume and in relation to urinary creatinine concentration
Measured: Day 1
Status of other micronutrients
Concentrations of micronutrients in serum and breast milk (vitamins E, B1, B2, B3, B5, B6, B7)
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202028 Feb 2022

First posted17 Nov 2020
Study start19 Oct 2020
Primary completion28 Feb 2022
Study completion28 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Iron DeficiencyStudies of the same condition, open and under way.
More trials run by University of California, DavisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 995 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04632771
Sponsor's protocol ID: 1536100
Status last verified: Apr 2022
First submitted: 27 Oct 2020
Last updated: 18 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Green MH, Lopez-Teros V, Green JB, Lietz G, Kumordzie SM, Oxley A, Fuseini AD, Nyaaba KW, Becher E, Davis JN, Wessells KR, Adu-Afarwuah S, Engle-Stone R, Haskell MJ. Use of Population-Based Compartmental Modeling and Retinol Isotope Dilution to Study Vitamin A Kinetics and Total Body Stores among Ghanaian Women of Reproductive Age. Curr Dev Nutr. 2024 Oct 18;8(11):104484. doi: 10.1016/j.cdnut.2024.104484. eCollection 2024 Nov.
PubMed 39634788
Davis JN, Kumordzie SM, Arnold CD, Wessells KR, Nyaaba KW, Adams KP, Tan XJ, Becher E, Vosti SA, Adu-Afarwuah S, Engle-Stone R. Consumption of Discretionary Salt and Salt from Bouillon among Households, Women, and Young Children in Northern Region, Ghana: A Mixed-Methods Study with the Condiment Micronutrient Innovation Trial (CoMIT) Project. Curr Dev Nutr. 2024 Feb 6;8(3):102088. doi: 10.1016/j.cdnut.2024.102088. eCollection 2024 Mar.
PubMed 38419834

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
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All Iron Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Evaluate the Nutritional Status of Women and Children in Northern Ghana, and Knowledge, Attitudes and Practices Related to Bouillon Cube Use
ClinicalTrials.gov ID: NCT04632771
Acronym / sponsor ID: 1536100
Conditions: Iron Deficiency, Vitamin A Deficiency, Vitamin B 12 Deficiency, Folate Deficiency, Zinc Deficiency, Dietary Habits
Study type: Observational
Recruitment status: Completed
Enrolment: 995 participants (actual)
Lead sponsor: University of California, DavisUniversity, hospital or other
Collaborators: University of Ghana, Newcastle University, Penn State University, Helen Keller International
Study start: 19 Oct 2020 (actual)
Primary completion: 28 Feb 2022 (actual)
Study completion: 28 Feb 2022 (actual)
First posted: 17 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Pilot survey: The investigators will recruit non-pregnant, non-lactating women of reproductive age, WRA (n = 250), children 2-5 years of age (n = 250), and lactating women (n= 250) who will be identified from households in selected communities using the random walk method. Information collected will include anthropometric and micronutrient status, hemoglobin concentration, inflammation, morbidity, household-level food consumption, and individual dietary intakes.
Retinol isotope dilution (RID) Pilot Study 1: The investigators will recruit non-pregnant and nonlactating women of reproductive age, WRA (n = 30) from a subset of the same communities as the pilot survey using the random walk method, and quantitatively estimate their total body vitamin A stores after consuming a dose of d6-labelled vitamin A. Total body stores of vitamin A will be estimated at 14 days after dosing.
Retinol isotope dilution (RID) Pilot Study 2 (kinetic study): Based on results from RID pilot study 1, the investigators will recruit non-pregnant and non-lactating women of reproductive age, WRA (n = 123) from a subset of the same communities as the pilot survey using the random walk method, to construct a population-level plasma retinol kinetic curve, after consuming a dose of d6-labelled vitamin A. A compartmental model will be fit to the plasma retinol kinetic data to develop population-specific coefficients for the RID prediction equation to quantitatively estimate total body vitamin A stores of WRA in the study population.
Formative research: The investigators will (a) conduct focus group discussions on knowledge, attitudes and practices related to salt and bouillon cube use, nutrition and health problems in the community, and micronutrient fortification; (b) perform a market assessment of the availability and cost of fortified, non-fortified and potentially fortifiable foods in the communities; and (c) observe how various local food recipes are prepared, including the types and quantities of ingredients used, and cooking duration and temperature.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 8

Arm	Type	Receives
Pilot survey: non-pregnant, non-lactating women	–	Other: N/A (observational study)Survey of non-pregnant, non-lactating women 15-49 years of age (n=250)
Pilot survey: lactating women	–	Other: N/A (observational study)Survey of lactating women 15-49 years of age who are currently breastfeeding a child 4-18 months of age (n=250)
Pilot survey: children	–	Other: N/A (observational study)Survey of children 2-5 years of age (n=250)
RID Pilot 1	–	Other: N/A (observational study)Two-week study to assess total body vitamin A stores in a sample of non-pregnant, non-lactating women 15-49 years of age (n=30)
RID Pilot 2	–	Other: N/A (observational study)Kinetic study with "Super-woman" design to develop a prediction equation to assess total body vitamin A stores among non-pregnant, non-lactating women 15-49 years of age (n=123)
Focus group discussions	–	Other: N/A (observational study)Focus group discussions conducted among women of reproductive age, older women, and men (n=120 total)
Market assessment	–	Other: N/A (observational study)Survey of retail outlets selling fortified staple foods and/or bouillon (n=50 shop owners or operators)
Recipe observations	–	Other: N/A (observational study)Observations of cooking of local dishes by selected participants (n=50) enrolled in the pilot survey.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Households in the urban and rural areas in Tolon and Kumbungu districts, in northern Ghana

Key inclusion criteria (12 listed)

non-pregnant, non-lactating woman of reproductive age (15-49 years) OR child 2-5 years of age OR non-pregnant lactating woman (4-18 mo post-partum, 15-49 years of age)
signed informed consent by participant (if adult woman) or by at least one parent or guardian (if child)
non-pregnant, nonlactating woman of reproductive age (15-49 years)
signed informed consent
planning to remain in the study area for the next 1 month

Key exclusion criteria (25 listed)

severe illness warranting hospital referral
chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially inferring with nutritional status
unable to provide informed consent due to impaired decision making abilities (if adult woman, or caretaker of potentially eligible child)
current participation in a clinical trial
RID Pilot 1

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
N/A (observational study)N/A (observational study)	Other	Focus group discussions, Market assessment, Pilot survey: children, Pilot survey: lactating women, Pilot survey: non-pregnant, non-lactating women, RID Pilot 1, RID Pilot 2, Recipe observations

Primary outcome

Hemoglobin
Time frame: Day 1
Hemoglobin concentration in venous blood (g/dL) among women and children
Iron status
Time frame: Day 1
Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children
Vitamin A status
Time frame: Day 1
Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children
Vitamin B12 status
Time frame: Day 1
Concentrations of vitamin B12 in serum among women and children
Folate status
Time frame: Day 1
Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)
Zinc status
Time frame: Day 1
Serum zinc concentration among women and children
Breast milk vitamin A concentration
Time frame: Day 1
Vitamin A concentration in breast milk, expressed per unit volume and per gram fat
Breast milk vitamin B12 concentration
Time frame: Day 1
Vitamin B12 concentration in breast milk
Total body vitamin A stores
Time frame: Day 7
Distribution of total body vitamin A stores among non-pregnant, non-lactating women, expressed as total mass and per gram of liver, estimated by retinol isotope dilution
Total body vitamin A stores
Time frame: Day 14
Distribution of total body vitamin A stores among non-pregnant, non-lactating women, expressed as total mass and per gram of liver, estimated by retinol isotope dilution
Coefficient "Fa"
Time frame: Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
Defined as the fraction of the oral tracer dose absorbed and retained in stores, estimated by modeling of data on labeled and unlabelled vitamin A in plasma collected using a "Super Woman" design and used to calculate total body stores for individual participants.
Coefficient "S"
Time frame: Blood samples from RID Pilot 2 participants collected at randomly assigned time points over a 90-day time frame
Defined as retinol specific activity in plasma/stores at time "t", estimated by modeling of data on labeled and unlabelled vitamin A in plasma collected using a "Super Woman" design and used to calculate total body stores for individual participants.
Prevalence of anemia and micronutrient deficiencies
Time frame: Day 1
Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs
Urinary iodine concentration
Time frame: Day 1
Iodine concentration of urine among women and children
Themes from focus group discussions
Time frame: Day 1
Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues
Recipe ingredients
Time frame: Day 1
Quantity of each recipe ingredient (including bouillon and salt) used in common local recipes; interpreted in relation to cooking duration and temperature (type and duration, e.g. of boiling) used in common recipes
Fortified food accessibility
Time frame: Day 1
Availability, price, and fortification levels of fortified food products in markets

15 secondary outcomes

Blood pressure
Time frame: Day 1
Hypertension
Time frame: Day 1
Height, cm
Time frame: Day 1
Weight, kg
Time frame: Day 1
Waist to hip ratio
Time frame: Day 1
Mid-upper arm circumference, cm
Time frame: Day 1
Anthropometric Z-scores
Time frame: Day 1
Prevalence of undernutrition
Time frame: Day 1
Prevalence of overweight and obesity
Time frame: Day 1
Morbidity symptoms
Time frame: Day 1
Inflammation
Time frame: Day 1
Household-food consumption
Time frame: Day 1
Individual dietary intake
Time frame: Day 1
Urinary sodium concentration
Time frame: Day 1
Status of other micronutrients
Time frame: Day 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
Derived from this study: PubMed 39634788Green MH, Lopez-Teros V, Green JB, Lietz G, Kumordzie SM, Oxley A, Fuseini AD, Nyaaba KW, Becher E, Davis JN, Wessells KR, Adu-Afarwuah S, Engle-Stone R, Haskell MJ. Use of Population-Based Compartmental Modeling and Retinol Isotope Dilution to Study Vitamin A Kinetics and Total Body Stores among Ghanaian Women of Reproductive Age. Curr Dev Nutr. 2024 Oct 18;8(11):104484. doi: 10.1016/j.cdnut.2024.104484. eCollection 2024 Nov.
Derived from this study: PubMed 38419834Davis JN, Kumordzie SM, Arnold CD, Wessells KR, Nyaaba KW, Adams KP, Tan XJ, Becher E, Vosti SA, Adu-Afarwuah S, Engle-Stone R. Consumption of Discretionary Salt and Salt from Bouillon among Households, Women, and Young Children in Northern Region, Ghana: A Mixed-Methods Study with the Condiment Micronutrient Innovation Trial (CoMIT) Project. Curr Dev Nutr. 2024 Feb 6;8(3):102088. doi: 10.1016/j.cdnut.2024.102088. eCollection 2024 Mar.
Individual participant dataSharing planned: Undecided

Related trials for Iron Deficiency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Iron Deficiency and Vitamin A Deficiency, run by University of California, Davis at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin (time frame: Day 1). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04632771, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.