Dietary Intake, Health and Micronutrient Status in Haiti

NCT04034381 | Terminated

• 2 other identifiers: 12845001718-68
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Micronutrient Deficiency; Malnutrition, Child; Malnutrition; Chronic Disease

Keywords

Micronutrient deficiency; Dietary intake; Food fortification; National survey

Outcome Measures

Primary Outcomes (9)

• Household-level consumption of "fortifiable" foods

  Measured using the Fortification Assessment Coverage Toolkit

  Previous 7 days

• Individual consumption of "fortifiable" foods

  Assessed using repeated 24-hour dietary recalls

  Previous 24 hours

• 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)

• Zinc status among women and children

  Plasma zinc concentration (micrograms per dL)

  Single time point (1 day)

• Iron status among women and children

  Plasma ferritin concentrations (micrograms per L)

  Single time point (1 day)

• Folate status among women

  Red blood cell folate concentrations (nmol/L)

  Single time point (1 day)

• Vitamin B12 status among women and children

  Plasma vitamin B12 concentrations (pmol/L)

  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)

  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)

  30 days (Previous month)

Secondary Outcomes (11)

• Body mass index among women

  Single time point (1 day)

• Mid-upper arm circumference among children

  Single time point (1 day)

• Height-for-age Z-score among children

  Single time point (1 day)

• Weight-for-age Z-score among children

  Single time point (1 day)

• Weight-for-length Z-score among children

  Single time point (1 day)

Study Arms (3)

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

No intervention (descriptive survey only) OTHER

No intervention

Other urban areas; Port-au-Prince metropolitan area; Rural areas

Eligibility Criteria

• Age: 6 Months - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Le Ministère de la Santé Publique et de la Population, Haiti: collaborator
• United States Agency for International Development (USAID): collaborator
• Global Alliance for Improved Nutrition: collaborator
• Partners of the Americas: collaborator

Study Sites (1)

Partners of the Americas

Pétionville, HT6141, Haiti

Location

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition; Chronic Disease

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseline Marhone Pierre, PhD

  Ministère de la Sante Publique et de la Population, Haiti

  STUDY CHAIR

• Reina Engle-Stone, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Stephen A Vosti, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: July 26, 2019
• Study Start: January 26, 2019
• Primary Completion: February 7, 2019
• Study Completion: February 7, 2019
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

HA (1)