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TerminatedNCT04034381Updated Jan 23, 2023

Dietary Intake, Health and Micronutrient Status in Haiti

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

Why this study was terminated
Study suspended due to civil unrest and corresponding safety concerns and logistical challenges.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
143
Ages
6 Months to 49 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

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

Keywords

  • Micronutrient deficiency
  • Dietary intake
  • Food fortification
  • National survey
03

In context

Child Nutrition Disorders

167 studies on the registry are indexed under Child Nutrition Disorders; 36 are open to participants now.

This study's enrollment of 143 is below the median of 300 across 32 observational studies indexed under Child Nutrition Disorders.

Browse Child Nutrition Disorders studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
143 participants (actual)
Patient registry
No

Groups and cohorts

  • Port-au-Prince metropolitan area

    Other: No intervention (descriptive survey only)

  • Other urban areas

    Other: No intervention (descriptive survey only)

  • Rural areas

    Other: No intervention (descriptive survey only)

Interventions

  • OtherNo intervention (descriptive survey only)

    No intervention

06

What researchers measure

Primary outcomes

  1. Household-level consumption of "fortifiable" foods

    Measured using the Fortification Assessment Coverage Toolkit

    Time frame: Previous 7 days

  2. Individual consumption of "fortifiable" foods

    Assessed using repeated 24-hour dietary recalls

    Time frame: Previous 24 hours

  3. 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)

  4. Zinc status among women and children

    Plasma zinc concentration (micrograms per dL)

    Time frame: Single time point (1 day)

  5. Iron status among women and children

    Plasma ferritin concentrations (micrograms per L)

    Time frame: Single time point (1 day)

  6. Folate status among women

    Red blood cell folate concentrations (nmol/L)

    Time frame: Single time point (1 day)

  7. Vitamin B12 status among women and children

    Plasma vitamin B12 concentrations (pmol/L)

    Time frame: Single time point (1 day)

  8. 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)

  9. 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)

Secondary outcomes

  1. Body mass index among women

    Body mass index, calculated as kg/m\^2

    Time frame: Single time point (1 day)

  2. Mid-upper arm circumference among children

    Mid-upper arm circumference, measured in mm

    Time frame: Single time point (1 day)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. Glucose concentration

    Glucose concentration in whole blood

    Time frame: Single time point (1 day)

  8. Concentration of total cholesterol

    Concentration of total cholesterol in whole blood, mg/dL

    Time frame: Single time point (1 day)

  9. Hemoglobin A1C concentrations

    Hemoglobin A1C concentrations in whole blood

    Time frame: Single time point (1 day)

  10. Concentration of HDL cholesterol

    Concentration of HDL cholesterol in whole blood, mg/dL

    Time frame: Single time point (1 day)

  11. Concentration of triglycerides

    Concentration of triglycerides in whole blood, mg/dL

    Time frame: Single time point (1 day)

07

Study locations

1 site
  • Partners of the Americas
    Pétion-Ville, HT6141, Haiti
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04034381
Collaborators
Le Ministère de la Santé Publique et de la Population, Haiti, United States Agency for International Development (USAID), Global Alliance for Improved Nutrition, Partners of the Americas
Responsible party
Sponsor
First posted
Jul 26, 2019
Start date
Jan 26, 2019
Primary completion
Feb 7, 2019
Completion
Feb 7, 2019
Last update
Jan 23, 2023

Study contacts

Joseline Marhone Pierre, PhD
study chair · Ministère de la Sante Publique et de la Population, Haiti
Reina Engle-Stone, PhD
principal investigator · University of California, Davis
Stephen A Vosti, PhD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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