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Dietary Intake, Health and Micronutrient Status in Haiti

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ClinicalTrials.gov Identifier: NCT04034381
Recruitment Status : Suspended (Study suspended due to civil unrest and corresponding safety concerns and logistical challenges.)
First Posted : July 26, 2019
Last Update Posted : January 28, 2021
Sponsor:
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
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment
Micronutrient Deficiency Malnutrition, Child Malnutrition Chronic Disease Other: No intervention (descriptive survey only)

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.

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Study Type : Observational
Estimated Enrollment : 1290 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Dietary Intake, Health and Micronutrient Status in Haiti: Establishing a Baseline to Manage and Evaluate a National Food Fortification Program
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
Port-au-Prince metropolitan area Other: No intervention (descriptive survey only)
No intervention

Other urban areas Other: No intervention (descriptive survey only)
No intervention

Rural areas Other: No intervention (descriptive survey only)
No intervention




Primary Outcome Measures :
  1. Household-level consumption of "fortifiable" foods [ Time Frame: Previous 7 days ]
    Measured using the Fortification Assessment Coverage Toolkit

  2. Individual consumption of "fortifiable" foods [ Time Frame: Previous 24 hours ]
    Assessed using repeated 24-hour dietary recalls

  3. Vitamin A status among women and children [ Time Frame: Single time point (1 day) ]
    Retinol in plasma or breast milk, and retinol-binding protein in plasma (micromol/L)

  4. Zinc status among women and children [ Time Frame: Single time point (1 day) ]
    Plasma zinc concentration (micrograms per dL)

  5. Iron status among women and children [ Time Frame: Single time point (1 day) ]
    Plasma ferritin concentrations (micrograms per L)

  6. Folate status among women [ Time Frame: Single time point (1 day) ]
    Red blood cell folate concentrations (nmol/L)

  7. Vitamin B12 status among women and children [ Time Frame: Single time point (1 day) ]
    Plasma vitamin B12 concentrations (pmol/L)

  8. Micronutrient content of wheat flour samples collected from markets and bakeries [ Time Frame: Single time point (1 day) ]
    Concentration of iron and zinc in wheat flour samples (mg/kg)

  9. Usual nutrient intakes among women and children [ Time Frame: 30 days (Previous month) ]
    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)


Secondary Outcome Measures :
  1. Body mass index among women [ Time Frame: Single time point (1 day) ]
    Body mass index, calculated as kg/m^2

  2. Mid-upper arm circumference among children [ Time Frame: Single time point (1 day) ]
    Mid-upper arm circumference, measured in mm

  3. Height-for-age Z-score among children [ Time Frame: Single time point (1 day) ]
    Height-for-age Z-score calculated using the WHO Growth Standard

  4. Weight-for-age Z-score among children [ Time Frame: Single time point (1 day) ]
    Weight-for-age Z-score calculated using the WHO Growth Standard

  5. Weight-for-length Z-score among children [ Time Frame: Single time point (1 day) ]
    Weight-for-length Z-score calculated using the WHO Growth Standard

  6. Prevalence of malnutrition among children [ Time Frame: Single time point (1 day) ]
    Prevalence of height-for-age, weight-for-age, or weight-for-height Z-score below <-2SD

  7. Glucose concentration [ Time Frame: Single time point (1 day) ]
    Glucose concentration in whole blood

  8. Concentration of total cholesterol [ Time Frame: Single time point (1 day) ]
    Concentration of total cholesterol in whole blood, mg/dL

  9. Hemoglobin A1C concentrations [ Time Frame: Single time point (1 day) ]
    Hemoglobin A1C concentrations in whole blood

  10. Concentration of HDL cholesterol [ Time Frame: Single time point (1 day) ]
    Concentration of HDL cholesterol in whole blood, mg/dL

  11. Concentration of triglycerides [ Time Frame: Single time point (1 day) ]
    Concentration of triglycerides in whole blood, mg/dL



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 49 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034381


Locations
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Haiti
Partners of the Americas
Pétion-Ville, Haiti, HT6141
Sponsors and Collaborators
University of California, Davis
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
Investigators
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Study Chair: Joseline Marhone Pierre, PhD Ministère de la Sante Publique et de la Population, Haiti
Principal Investigator: Reina Engle-Stone, PhD University of California, Davis
Principal Investigator: Stephen A Vosti, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04034381    
Other Study ID Numbers: 1284500
1718-68 ( Other Identifier: Comité National de Bioéthique, Haiti )
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Micronutrient deficiency
Dietary intake
Food fortification
National survey
Additional relevant MeSH terms:
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Malnutrition
Child Nutrition Disorders
Chronic Disease
Nutrition Disorders
Disease Attributes
Pathologic Processes