Prevalence of Iodine Deficiency in Remote Communities of Haiti

Iodine Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275452
• Other study ID #: ARCH
• Status: Recruiting
• Start date: February 7, 2022
• Est. completion date: May 2022

Study information

• Verified date: March 2022
• Source: Swiss Federal Institute of Technology
• Contact: Jessica Rigutto, PhD
• Phone: +41 632 43 69
• Email: jessica.rigutto[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Iodine Deficiency

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Haiti	Université Notre Dame d'Haiti	Hinche

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Université Notre Dame d'Haiti UDERS de Hinche, Haiti, University of Notre Dame

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary iodine concentration	iodine measured in a spot sample of urine	through study completion, estimated 2 to 3 months