Prevalence of Iodine Deficiency in Remote Communities of Haiti

Sponsor
Swiss Federal Institute of Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT05275452
Collaborator
University of Notre Dame (Other), Université Notre Dame d'Haiti UDERS de Hinche, Haiti (Other)
800
1
2.7
293.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
800 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Assessing the Prevalence of Iodine Deficiency in Remote Communities of the Central Plateau, Haiti: a Cross-sectional Study (ARCH)
Actual Study Start Date :
Feb 7, 2022
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Urinary iodine concentration [through study completion, estimated 2 to 3 months]

    iodine measured in a spot sample of urine

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 44 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Université Notre Dame d'Haiti Hinche Haiti 1594

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jessica Rigutto, PhD, ETH Zürich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT05275452
Other Study ID Numbers:
  • ARCH
First Posted:
Mar 11, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 11, 2022