Dietary Intake, Health and Micronutrient Status in Haiti

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04034381
• Other study ID #: 1284500
• Secondary ID: 1718-68
• Status: Terminated
• Start date: January 26, 2019
• Est. completion date: February 7, 2019

Study information

• Verified date: January 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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: 1. To describe the prevalence, at national and subnational levels, of anemia and selected micronutrient deficiencies among women and young children in Haiti (in addition to health indicators such as systemic inflammation, malaria infection, and anthropometric indices), to serve as a reference point for management and evaluation of a large-scale food fortification program, and other nutrition-related programs. 2. To measure dietary intake of micronutrients and potentially fortifiable foods, using 24-hour dietary recalls and the Fortification Assessment Coverage Toolkit (FACT), to confirm appropriate food vehicles for fortification, and to determine the specific micronutrients and fortification levels to be included in the program. 3. To measure micronutrient content in wheat flour samples collected from households, markets and/or bakeries to assess the current reach and fortification levels of fortified wheat flour. 4. To collect information on access to and use of public and private health care services and government programs (including food aid), to identify platforms, and their associated costs, for delivering nutrition programs to individuals not reached by large-scale food fortification. 5. To assess biological and behavioral risk factors for noncommunicable diseases, including blood glucose and lipid levels, to identify associations with health and nutritional status among women. 6. To measure micronutrient concentrations in human milk to assess micronutrient status of mothers and micronutrient intake of breastfeeding children. 7. To collect images to assist in the development of a novel digital anthropometric assessment method (technology for measurement of body size using photos). 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Chronic Disease
• Malnutrition
• Malnutrition, Child
• Micronutrient Deficiency

Intervention

Other:
• No intervention (descriptive survey only)
No intervention

Locations

Country	Name	City	State
Haiti	Partners of the Americas	Pétion-Ville

Sponsors (5)

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)

Country where clinical trial is conducted

Haiti, 

Outcome

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)