An observational study in Micronutrient Deficiency, Malnutrition, Child and Malnutrition, sponsored by University of California, Davis. Terminated at 1 site in Haiti. Open to participants aged 6 Months to 49 Years. Per ClinicalTrials.gov, last updated 2023-01-23.
Sponsored by University of California, Davis · 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.
Women of reproductive age and young children are especially vulnerable to micronutrient deficiencies which may lead to life-long disabilities. In Haiti, deficiencies in micronutrients such as iron, zinc, and vitamin A, are likely prevalent, but recent national estimates of the burden are not available. The most recent Demographic and Health Survey reported that 49% of women of reproductive age and 66% of preschool children were anemic. In addition, the Haitian population also has a high prevalence of overweight and obesity, with 38.5% classified as either overweight or obese. Fortification of staple foods with micronutrients is considered a cost-effective intervention to reduce the burden of micronutrient deficiencies. Through the Copenhagen Consensus Haiti Priorise exercise, fortification of flour with iron and folic acid was identified as the Number 2 development priority for Haiti. Prior to implementing a large-scale fortification program, however, the World Health Organization recommends the collection of detailed baseline information on nutritional status and dietary intake in the target population. In addition, information on certain biochemical indicators of nutritional status is needed to confirm the need for program implementation and to establish a baseline for later program evaluation and modification. Data on dietary patterns and nutrient intake are needed to 1) adapt nutrition intervention programs to match dietary nutrient gaps, and 2) design and manage complementary programs to address nutritional deficiencies in at-risk population subgroups that may not be reached or effectively covered by large-scale fortification programs.
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 later program evaluation.
The specific objectives of the project are:
The study will be designed as a stratified cluster survey with three ecological strata. Enumeration areas (clusters) and households within each cluster will be selected such that the sample is representative at the stratum level and national level.
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This study's enrollment of 143 is below the median of 300 across 32 observational studies indexed under Child Nutrition Disorders.
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The study will be designed as a stratified cluster survey with 3 ecological strata. Enumeration areas (clusters) and households within each cluster will be selected such that the sample is representative at the stratum level and national level. The study will include households in which there is a child 6-59 months of age and a woman 15-49 years of age who serves as the child's primary caregiver.
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Exclusion Criteria:
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.
Other: No intervention (descriptive survey only)
Other: No intervention (descriptive survey only)
Other: No intervention (descriptive survey only)
No intervention
Household-level consumption of "fortifiable" foods
Measured using the Fortification Assessment Coverage Toolkit
Time frame: Previous 7 days
Individual consumption of "fortifiable" foods
Assessed using repeated 24-hour dietary recalls
Time frame: Previous 24 hours
Vitamin A status among women and children
Retinol in plasma or breast milk, and retinol-binding protein in plasma (micromol/L)
Time frame: Single time point (1 day)
Zinc status among women and children
Plasma zinc concentration (micrograms per dL)
Time frame: Single time point (1 day)
Iron status among women and children
Plasma ferritin concentrations (micrograms per L)
Time frame: Single time point (1 day)
Folate status among women
Red blood cell folate concentrations (nmol/L)
Time frame: Single time point (1 day)
Vitamin B12 status among women and children
Plasma vitamin B12 concentrations (pmol/L)
Time frame: Single time point (1 day)
Micronutrient content of wheat flour samples collected from markets and bakeries
Concentration of iron and zinc in wheat flour samples (mg/kg)
Time frame: Single time point (1 day)
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)
Time frame: 30 days (Previous month)
Body mass index among women
Body mass index, calculated as kg/m\^2
Time frame: Single time point (1 day)
Mid-upper arm circumference among children
Mid-upper arm circumference, measured in mm
Time frame: Single time point (1 day)
Height-for-age Z-score among children
Height-for-age Z-score calculated using the WHO Growth Standard
Time frame: Single time point (1 day)
Weight-for-age Z-score among children
Weight-for-age Z-score calculated using the WHO Growth Standard
Time frame: Single time point (1 day)
Weight-for-length Z-score among children
Weight-for-length Z-score calculated using the WHO Growth Standard
Time frame: Single time point (1 day)
Prevalence of malnutrition among children
Prevalence of height-for-age, weight-for-age, or weight-for-height Z-score below \<-2SD
Time frame: Single time point (1 day)
Glucose concentration
Glucose concentration in whole blood
Time frame: Single time point (1 day)
Concentration of total cholesterol
Concentration of total cholesterol in whole blood, mg/dL
Time frame: Single time point (1 day)
Hemoglobin A1C concentrations
Hemoglobin A1C concentrations in whole blood
Time frame: Single time point (1 day)
Concentration of HDL cholesterol
Concentration of HDL cholesterol in whole blood, mg/dL
Time frame: Single time point (1 day)
Concentration of triglycerides
Concentration of triglycerides in whole blood, mg/dL
Time frame: Single time point (1 day)
Plan to share: No
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This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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