Anemia Clinical Trial
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
NCT number | NCT04632771 |
Other study ID # | 1536100 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 19, 2020 |
Est. completion date | February 28, 2022 |
Verified date | April 2022 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 995 |
Est. completion date | February 28, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years and older |
Eligibility | Pilot survey Inclusion Criteria: - 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) Exclusion Criteria: - 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 Inclusion Criteria: - 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 Exclusion Criteria: - 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 RID Pilot 2 Inclusion Criteria: - 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 Exclusion Criteria: - 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 Inclusion Criteria: - Adults (including women, men, and other key community members such as merchants, etc.) - Provision of written informed consent |
Country | Name | City | State |
---|---|---|---|
Ghana | University of Ghana | Accra |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | Helen Keller International, Newcastle University, Penn State University, University of Ghana |
Ghana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Micronutrient supplement use | Reported use of daily or periodic micronutrient supplements in the past month | Day 1 | |
Other | Consumption of fruits and vegetables | Assessed using the WHO STEPS questionnaire | Day 1 | |
Other | Consumption of snacks and sweetened beverages | Assessed using the WHO STEPS questionnaire | Day 1 | |
Other | Physical activity | Assessed using the WHO STEPS questionnaire | Day 1 | |
Other | Tobacco use | Assessed using the WHO STEPS questionnaire | Day 1 | |
Other | Alcohol use | Assessed using the WHO STEPS questionnaire | Day 1 | |
Primary | Hemoglobin | Hemoglobin concentration in venous blood (g/dL) among women and children | Day 1 | |
Primary | Iron status | Concentrations of iron status biomarkers (serum iron, ferritin, and soluble transferrin receptor) among women and children | Day 1 | |
Primary | Vitamin A status | Concentrations of vitamin A status biomarkers (serum retinol and retinol-binding protein) among women and children | Day 1 | |
Primary | Vitamin B12 status | Concentrations of vitamin B12 in serum among women and children | Day 1 | |
Primary | Folate status | Concentrations of folate in serum (among women and children) and whole blood and erythrocytes (women only) | Day 1 | |
Primary | Zinc status | Serum zinc concentration among women and children | Day 1 | |
Primary | Breast milk vitamin A concentration | Vitamin A concentration in breast milk, expressed per unit volume and per gram fat | Day 1 | |
Primary | Breast milk vitamin B12 concentration | Vitamin B12 concentration in breast milk | Day 1 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Prevalence of anemia and micronutrient deficiencies | Prevalence of hemoglobin and micronutrient biomarkers above or below relevant cutoffs | Day 1 | |
Primary | Urinary iodine concentration | Iodine concentration of urine among women and children | Day 1 | |
Primary | Themes from focus group discussions | Perceptions of bouillon and salt use, cooking practices, noncommunicable disease, and other nutrition and diet-related issues | Day 1 | |
Primary | 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 | |
Primary | Fortified food accessibility | Availability, price, and fortification levels of fortified food products in markets | Day 1 | |
Secondary | Blood pressure | Blood pressure measured among women and children (mm Hg, systolic and diastolic) | Day 1 | |
Secondary | Hypertension | Prevalence of blood pressure measurements above cutoffs for hypertension | Day 1 | |
Secondary | Height, cm | Standing height measured among women and children | Day 1 | |
Secondary | Weight, kg | Weight measurement among women and children | Day 1 | |
Secondary | Waist to hip ratio | Waist and hip circumference (measured in cm) among women and their ratio | Day 1 | |
Secondary | Mid-upper arm circumference, cm | Mid-upper arm circumference measured among children | Day 1 | |
Secondary | 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) | Day 1 | |
Secondary | Prevalence of undernutrition | Prevalence of anthropometric Z-scores or mid-upper arm circumference below WHO cutoffs to indicate child undernutrition | Day 1 | |
Secondary | Prevalence of overweight and obesity | Prevalence of body mass index (women) or BMI-for-age Z-score (children) above WHO cutoffs | Day 1 | |
Secondary | Morbidity symptoms | Reported malaria, diarrhea, fever, or vomiting in the past 7 days (all survey participants) | Day 1 | |
Secondary | Inflammation | Serum concentrations of CRP, AGP, amyloid A, MCP-1, IL-6, IL-10, IL-1b, adiponectin | Day 1 | |
Secondary | 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 | Day 1 | |
Secondary | 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 | Day 1 | |
Secondary | Urinary sodium concentration | Expressed per unit volume and in relation to urinary creatinine concentration | Day 1 | |
Secondary | Status of other micronutrients | Concentrations of micronutrients in serum and breast milk (vitamins E, B1, B2, B3, B5, B6, B7) | Day 1 |
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