Micronutrient DeficiencyNCT04034381
Dietary Intake, Health and Micronutrient Status in Haiti
An observational study of Micronutrient Deficiency and Malnutrition, Child, run by University of California, Davis at 1 site in Haiti.
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… Read more about this study
- Who is it for?
- Ages 6 months to 49 years
- Conditions the study is for
- Micronutrient Deficiency, Malnutrition, Child, Malnutrition
- How many people
- 143 participants
- Where
- 1 siteHaiti
- Study dates
- 26 Jan 2019to 7 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Intake, Health and Micronutrient Status in Haiti: Establishing a Baseline to Manage and Evaluate a National Food Fortification Program
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- To measure micronutrient concentrations in human milk to assess micronutrient status of mothers and micronutrient intake of breastfeeding children.
- 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.
- Being tested
- No intervention (descriptive survey only)
- Keywords
- Micronutrient deficiency, Dietary intake, Food fortification, National survey
- Medical subject headings
- Child Nutrition Disorders, Malnutrition, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (descriptive survey only)Other
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Port-au-Prince metropolitan area | Not described Receives: Other: No intervention (descriptive survey only) | |
| Other urban areas | Not described Receives: Other: No intervention (descriptive survey only) | |
| Rural areas | Not described Receives: Other: No intervention (descriptive survey only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household-level consumption of "fortifiable" foods
Measured using the Fortification Assessment Coverage Toolkit
Measured: Previous 7 days
Individual consumption of "fortifiable" foods
Assessed using repeated 24-hour dietary recalls
Measured: Previous 24 hours
Vitamin A status among women and children
Retinol in plasma or breast milk, and retinol-binding protein in plasma (micromol/L)
Measured: Single time point (1 day)
Zinc status among women and children
Plasma zinc concentration (micrograms per dL)
Measured: Single time point (1 day)
Iron status among women and children
Plasma ferritin concentrations (micrograms per L)
Measured: Single time point (1 day)
Folate status among women
Red blood cell folate concentrations (nmol/L)
Measured: Single time point (1 day)
Vitamin B12 status among women and children
Plasma vitamin B12 concentrations (pmol/L)
Measured: 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)
Measured: 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)
Measured: 30 days (Previous month)
Secondary outcomes (11)
Body mass index among women
Body mass index, calculated as kg/m^2
Measured: Single time point (1 day)
Mid-upper arm circumference among children
Mid-upper arm circumference, measured in mm
Measured: Single time point (1 day)
Height-for-age Z-score among children
Height-for-age Z-score calculated using the WHO Growth Standard
Measured: Single time point (1 day)
Weight-for-age Z-score among children
Weight-for-age Z-score calculated using the WHO Growth Standard
Measured: Single time point (1 day)
Weight-for-length Z-score among children
Weight-for-length Z-score calculated using the WHO Growth Standard
Measured: 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
Measured: Single time point (1 day)
Glucose concentration
Glucose concentration in whole blood
Measured: Single time point (1 day)
Concentration of total cholesterol
Concentration of total cholesterol in whole blood, mg/dL
Measured: Single time point (1 day)
Hemoglobin A1C concentrations
Hemoglobin A1C concentrations in whole blood
Measured: Single time point (1 day)
Concentration of HDL cholesterol
Concentration of HDL cholesterol in whole blood, mg/dL
Measured: Single time point (1 day)
Concentration of triglycerides
Concentration of triglycerides in whole blood, mg/dL
Measured: Single time point (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start26 Jan 2019
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Why it stopped: Study suspended due to civil unrest and corresponding safety concerns and logistical challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micronutrient DeficiencyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Joseline Marhone Pierre, PhD, Study chair, Ministère de la Sante Publique et de la Population, HaitiReina Engle-Stone, PhD, Principal investigator, University of California, DavisStephen A Vosti, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034381
- Sponsor's protocol ID
- 1284500
- Other IDs
- 1718-68
- Status last verified
- Jan 2023
- First submitted
- 27 Feb 2019
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake, Health and Micronutrient Status in Haiti: Establishing a Baseline to Manage and Evaluate a National Food Fortification Program
- ClinicalTrials.gov ID
- NCT04034381
- Acronym / sponsor ID
- 1284500
- Keywords
- Micronutrient deficiency, Dietary intake, Food fortification, National survey
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study suspended due to civil unrest and corresponding safety concerns and logistical challenges.
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- 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
- Study start
- 26 Jan 2019 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- To measure micronutrient concentrations in human milk to assess micronutrient status of mothers and micronutrient intake of breastfeeding children.
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (descriptive survey only)No intervention | Other | Other urban areas, Port-au-Prince metropolitan area, Rural areas |
Primary outcome
Household-level consumption of "fortifiable" foods
Time frame: Previous 7 days
Measured using the Fortification Assessment Coverage Toolkit
Individual consumption of "fortifiable" foods
Time frame: Previous 24 hours
Assessed using repeated 24-hour dietary recalls
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)
Zinc status among women and children
Time frame: Single time point (1 day)
Plasma zinc concentration (micrograms per dL)
Iron status among women and children
Time frame: Single time point (1 day)
Plasma ferritin concentrations (micrograms per L)
Folate status among women
Time frame: Single time point (1 day)
Red blood cell folate concentrations (nmol/L)
Vitamin B12 status among women and children
Time frame: Single time point (1 day)
Plasma vitamin B12 concentrations (pmol/L)
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)
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)
11 secondary outcomes
Body mass index among women
Time frame: Single time point (1 day)
Mid-upper arm circumference among children
Time frame: Single time point (1 day)
Height-for-age Z-score among children
Time frame: Single time point (1 day)
Weight-for-age Z-score among children
Time frame: Single time point (1 day)
Weight-for-length Z-score among children
Time frame: Single time point (1 day)
Prevalence of malnutrition among children
Time frame: Single time point (1 day)
Glucose concentration
Time frame: Single time point (1 day)
Concentration of total cholesterol
Time frame: Single time point (1 day)
Hemoglobin A1C concentrations
Time frame: Single time point (1 day)
Concentration of HDL cholesterol
Time frame: Single time point (1 day)
Concentration of triglycerides
Time frame: Single time point (1 day)
Results and safety
The study was stopped early (reason given: Study suspended due to civil unrest and corresponding safety concerns and logistical challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Micronutrient Deficiency
Active, not recruiting
Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
Pregnancy
RecruitingObservational study
Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
Bariatric Surgery, Pregnency
Recruiting
Implementation of Multiple Micronutrient Supplementation (MMS) for Pregnant Women in Uganda
Nutrient Deficiency
Not yet recruitingPhase 4
Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia
Iodine Deficiency, Nutrition Poor
RecruitingPhase 3
Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
Anemia, Iron Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Micronutrient Deficiency and Malnutrition, Child, run by University of California, Davis at 1 site in Haiti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study suspended due to civil unrest and corresponding safety concerns and logistical challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household-level consumption of "fortifiable" foods (time frame: Previous 7 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.