Malnutrition Clinical Trial
Official title:
Dietary Intake, Health and Micronutrient Status in Haiti: Establishing a Baseline to Manage and Evaluate a National Food Fortification Program
Verified date | January 2023 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The general objective of this project is to collect information on dietary intake and nutritional status of women and young children in Haiti, to inform the design and management of national and subnational micronutrient intervention programs, with a focus on large-scale food fortification, and to serve as a reference point for program evaluation.
Status | Terminated |
Enrollment | 143 |
Est. completion date | February 7, 2019 |
Est. primary completion date | February 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 49 Years |
Eligibility | Inclusion Criteria: - There is at least one child 6-59 months of age (the index child) in the household - The primary or secondary female caregiver of the child who is 15-49 years of age (the index caregiver) is present in the household Exclusion Criteria: - The index child or index caregiver has fever, diarrhea with dehydration, or another serious health problem, or had any one of these conditions beginning on the day before the eligibility interview. In addition, any lactating woman in the household is eligible for inclusion in the human milk assessment if she is breastfeeding an infant that is at least 30 days old. The lactating woman will be excluded from participating in the human milk assessment if she has a fever, diarrhea with dehydration, or another serious health problem, or had any of these conditions beginning on the day before the eligibility interview. |
Country | Name | City | State |
---|---|---|---|
Haiti | Partners of the Americas | Pétion-Ville |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | Global Alliance for Improved Nutrition, Le Ministère de la Santé Publique et de la Population, Haiti, Partners of the Americas, United States Agency for International Development (USAID) |
Haiti,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Household-level consumption of "fortifiable" foods | Measured using the Fortification Assessment Coverage Toolkit | Previous 7 days | |
Primary | Individual consumption of "fortifiable" foods | Assessed using repeated 24-hour dietary recalls | Previous 24 hours | |
Primary | Vitamin A status among women and children | Retinol in plasma or breast milk, and retinol-binding protein in plasma (micromol/L) | Single time point (1 day) | |
Primary | Zinc status among women and children | Plasma zinc concentration (micrograms per dL) | Single time point (1 day) | |
Primary | Iron status among women and children | Plasma ferritin concentrations (micrograms per L) | Single time point (1 day) | |
Primary | Folate status among women | Red blood cell folate concentrations (nmol/L) | Single time point (1 day) | |
Primary | Vitamin B12 status among women and children | Plasma vitamin B12 concentrations (pmol/L) | Single time point (1 day) | |
Primary | Micronutrient content of wheat flour samples collected from markets and bakeries | Concentration of iron and zinc in wheat flour samples (mg/kg) | Single time point (1 day) | |
Primary | Usual nutrient intakes among women and children | Estimated population usual intakes of energy, fat, protein, carbohydrate, vitamin A, iron, zinc, folate, vitamin B12, thiamin, riboflavin, and niacin (based on combined data from 24-h dietary recalls and 30-day supplement questionnaire) | 30 days (Previous month) | |
Secondary | Body mass index among women | Body mass index, calculated as kg/m^2 | Single time point (1 day) | |
Secondary | Mid-upper arm circumference among children | Mid-upper arm circumference, measured in mm | Single time point (1 day) | |
Secondary | Height-for-age Z-score among children | Height-for-age Z-score calculated using the WHO Growth Standard | Single time point (1 day) | |
Secondary | Weight-for-age Z-score among children | Weight-for-age Z-score calculated using the WHO Growth Standard | Single time point (1 day) | |
Secondary | Weight-for-length Z-score among children | Weight-for-length Z-score calculated using the WHO Growth Standard | Single time point (1 day) | |
Secondary | Prevalence of malnutrition among children | Prevalence of height-for-age, weight-for-age, or weight-for-height Z-score below <-2SD | Single time point (1 day) | |
Secondary | Glucose concentration | Glucose concentration in whole blood | Single time point (1 day) | |
Secondary | Concentration of total cholesterol | Concentration of total cholesterol in whole blood, mg/dL | Single time point (1 day) | |
Secondary | Hemoglobin A1C concentrations | Hemoglobin A1C concentrations in whole blood | Single time point (1 day) | |
Secondary | Concentration of HDL cholesterol | Concentration of HDL cholesterol in whole blood, mg/dL | Single time point (1 day) | |
Secondary | Concentration of triglycerides | Concentration of triglycerides in whole blood, mg/dL | Single time point (1 day) |
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