Prevalence of Iodine Deficiency in Remote Communities of Haiti

Assessing the Prevalence of Iodine Deficiency in Remote Communities of the Central Plateau, Haiti: a Cross-sectional Study (ARCH)

Haiti is one of the few remaining countries that is at risk of iodine deficiency disorders. In the 2018 survey, iodized salt was found in <20% of households and iodine excretion from non-pregnant and pregnant women suggested inadequate intakes, with those in remote inland settings most at risk.

The Haiti Salt Program (HSP) was established in 2006 at the University of Notre Dame, US (UND). Using a self-sustaining business model that protects the livelihoods of all who work within it, the HSP has a goal of supplying fortified salt to combat IDD and lymphatic filariasis. HSP purchases salt from local small producers for processing in a local factory equipped with robust, standardized and controlled facilities that iodizes the salt under correct conditions, ready for fair resale to the consumer. The salt is currently distributed in the West Department, though a country-wide roll-out is envisaged. This initiative has the potential to accelerate optimization of population iodine intake across Haiti and through IDD prevention, positively contributing to the development of the country.

Data on iodine status and intake of native iodine-rich foods, iodized salt and other iodine-fortified foods e.g., bouillon cubes in Haiti, are sparse, particularly from rural and remote locations. An update on the situation in such remote areas in Haiti is trequired, to inform and leverage the development and implementation of iodized salt policy in the region.

The specific objective of this study is to assess the iodine status of two representative population subgroups, namely school-age children and women of reproductive age, in a remote region of the Central Plateau of Haiti. We hypothesize that the mUIC will indicate population iodine insufficiency in both of these population groups.

Study Overview

• Status: Recruiting
• Conditions: Iodine Deficiency
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Jessica Rigutto, PhD; Phone Number: +41 632 43 69; Email: jessica.rigutto@hest.ethz.ch

Study Locations

• Haiti
  • Hinche, Haiti, 1594
    • Recruiting
    • Université Notre Dame d'Haiti
    • Contact: Herald Herald, PhD; Phone Number: +509 37374850; Email: vreu.udershinche@undh.edu.ht
    • Principal Investigator: Herald Jean, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 44 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The Central Plateau/Center Department is a predominantly rural Department in the Center/Northern part of Haiti. The Central Plateau is divided into the haut (upper) and bas (lower) plateau and covers an area of about 150 square miles (390 square km). The average elevation is about 1,000 feet (300 metres), and road access throughout the department is limited, with many areas accessible only by donkey/horse, motorcycle, or on foot. The Cahos Mountains form the western border of the department and the Noires Mountains form the southern border. Hinche is based largely on farming, raising of livestock, and trade.

Description

We will recruit school age children (male and female, aged 9-13 years) and women of reproductive age (aged 18-44 years).

The inclusion criteria for all subjects will be:

1. residence within the study area for ≥12 months;
2. general good health as assessed by no reported treatment for chronic disease;
3. no known history of goiter or other thyroid disease;
4. no exposure to iodine containing contrast agent or medication within the last year;
5. Women of reproductive age should not currently be pregnant or be breastfeeding, assessed by asking the women.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
School age children aged 9-13 years	Other: No intervention; No intervention
Women of reproductive age aged 18-44 years	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary iodine concentration	iodine measured in a spot sample of urine	through study completion, estimated 2 to 3 months

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: University of Notre Dame; Université Notre Dame d'Haiti UDERS de Hinche, Haiti
• Investigators: Principal Investigator: Jessica Rigutto, PhD, ETH Zurich

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ARCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No