ClinicalTrials.gg
Status unknownNCT05275452Updated Mar 11, 2022

Prevalence of Iodine Deficiency in Remote Communities of Haiti

An observational study in Iodine Deficiency, sponsored by Swiss Federal Institute of Technology. Status unknown at 1 site in Haiti. Open to participants aged 9 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-11.

Sponsored by Swiss Federal Institute of Technology · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
800
Ages
9 Years to 44 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Iodine Deficiency
03

In context

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 44 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

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.
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • School age children aged 9-13 years

    Other: No intervention

  • Women of reproductive age aged 18-44 years

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Urinary iodine concentration

    iodine measured in a spot sample of urine

    Time frame: through study completion, estimated 2 to 3 months

07

Study locations

1 of 1 sites recruiting
  • Université Notre Dame d'Haiti
    Hinche, 1594, Haiti
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2022 (actual). Primary completion is estimated for May 2022, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2022
First posted
Mar 11, 2022
StartActual
Feb 7, 2022
Primary completionEst.
May 2022
CompletionEst.
May 2022
Last update
Mar 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05275452
Collaborators
University of Notre Dame, Université Notre Dame d'Haiti UDERS de Hinche, Haiti
Responsible party
Sponsor
First posted
Mar 11, 2022
Start date
Feb 7, 2022
Primary completion
May 2022 (estimated)
Completion
May 2022 (estimated)
Last update
Mar 11, 2022

Study contacts

Jessica Rigutto, PhD
Contact
jessica.rigutto@hest.ethz.ch
+41 632 43 69
Jessica Rigutto, PhD
principal investigator · ETH Zürich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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