Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04034381
Other study ID # 1284500
Secondary ID 1718-68
Status Terminated
Phase
First received
Last updated
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
Health authority
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.

Study Design


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)
See also
  Status Clinical Trial Phase
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03268902 - Early Life Interventions for Childhood Growth and Development In Tanzania Phase 2/Phase 3
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT04608656 - Livestock for Health Project N/A
Completed NCT06009198 - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan N/A
Recruiting NCT05417672 - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting NCT05257980 - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03628196 - A Nutrition-Focused QIP in Outpatient Clinics
Enrolling by invitation NCT04675229 - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Not yet recruiting NCT06047054 - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT03150927 - Clinical Study of Novel Probiotic Microbial Compositeā„¢ to Treat Undernourished Young Children N/A
Recruiting NCT03408067 - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients N/A
Recruiting NCT02833740 - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition N/A
Completed NCT02938234 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake N/A
Completed NCT02938247 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake N/A