Nutritional Status and Bouillon Use in Northern Ghana

NCT04632771 | Completed

• 1 other identifier: 1536100
• Study Type: observational
• Target: 995
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency; Vitamin A Deficiency; Vitamin B 12 Deficiency; Folate Deficiency; Zinc Deficiency; Dietary Habits; Anemia

Outcome Measures

Primary Outcomes (17)

• Hemoglobin

  Hemoglobin concentration in venous blood (g/dL) among women and children

  Day 1

• Iron status

  Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children

  Day 1

• Vitamin A status

  Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children

  Day 1

• Vitamin B12 status

  Concentrations of vitamin B12 in serum among women and children

  Day 1

• Folate status

  Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only)

  Day 1

• Zinc status

  Serum zinc concentration among women and children

  Day 1

• Breast milk vitamin A concentration

  Vitamin A concentration in breast milk, expressed per unit volume and per gram fat

  Day 1

• Breast milk vitamin B12 concentration

  Vitamin B12 concentration in breast milk

  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

  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

  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.

  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.

  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

  Day 1

• Urinary iodine concentration

  Iodine concentration of urine among women and children

  Day 1

• Themes from focus group discussions

  Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues

  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

  Day 1

• Fortified food accessibility

  Availability, price, and fortification levels of fortified food products in markets

  Day 1

Secondary Outcomes (15)

• Blood pressure

  Day 1

• Hypertension

  Day 1

• Height, cm

  Day 1

• Weight, kg

  Day 1

• Waist to hip ratio

  Day 1

Other Outcomes (6)

• Micronutrient supplement use

  Day 1

• Consumption of fruits and vegetables

  Day 1

• Consumption of snacks and sweetened beverages

  Day 1

Study Arms (8)

Pilot survey: non-pregnant, non-lactating women

Survey of non-pregnant, non-lactating women 15-49 years of age (n=250)

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)

Other: N/A (observational study)

Pilot survey: children

Survey of children 2-5 years of age (n=250)

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)

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)

Other: N/A (observational study)

Focus group discussions

Focus group discussions conducted among women of reproductive age, older women, and men (n=120 total)

Other: N/A (observational study)

Market assessment

Survey of retail outlets selling fortified staple foods and/or bouillon (n=50 shop owners or operators)

Other: N/A (observational study)

Recipe observations

Observations of cooking of local dishes by selected participants (n=50) enrolled in the pilot survey.

Other: N/A (observational study)

Interventions

N/A (observational study) OTHER

N/A (observational study)

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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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
• 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

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 (2)

• 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.

  PMID: 39634788 DERIVED

• 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.

  PMID: 38419834 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

In the pilot survey, samples of whole blood will be collected from women of reproductive age for assessment of folate status. Samples of serum, plasma, washed red blood cells, and urine will be collected from women and children, and breast milk will be collected from lactating women. Samples will be analyzed for indicators of micronutrient status and inflammation as described in the protocol (DNA analyses will not be conducted).

MeSH Terms

Conditions

Iron Deficiencies; Vitamin A Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Feeding Behavior; Anemia

Interventions

Observation

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamin B Deficiency; Behavior, Animal; Behavior; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 17, 2020
• Study Start: October 19, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

GH (1)