Iodine DeficiencyNCT05275452
Prevalence of Iodine Deficiency in Remote Communities of Haiti
An observational study of Iodine Deficiency, run by Swiss Federal Institute of Technology at 1 site in Haiti.
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. Read more about this study
- Who is it for?
- Ages 9 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- How many people
- 800 participants
- Where
- 1 siteHaiti
- Study dates
- 7 Feb 2022to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 44 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
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:
- residence within the study area for ≥12 months;
- general good health as assessed by no reported treatment for chronic disease;
- no known history of goiter or other thyroid disease;
- no exposure to iodine containing contrast agent or medication within the last year;
- Women of reproductive age should not currently be pregnant or be breastfeeding, assessed by asking the women.
Trial locations and contacts
1 site in 1 country.
Haiti1 site, 1 recruiting
- Recruiting
Université Notre Dame d'Haiti
Hinche, 1594
Herald Herald, PhD, +509 37374850, vreu.udershinche@undh.edu.ht
Herald Jean, PhD
About this study
Official title: 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.
Read more
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.
- Conditions
- Iodine Deficiency
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| School age children aged 9-13 years | Not described Receives: Other: No intervention | |
| Women of reproductive age aged 18-44 years | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine concentration
iodine measured in a spot sample of urine
Measured: through study completion, estimated 2 to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start7 Feb 2022
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Notre Dame, Université Notre Dame d'Haiti UDERS de Hinche, Haiti
- Responsible party
- Sponsor
- Investigators
- Jessica Rigutto, PhD, Principal investigator, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275452
- Sponsor's protocol ID
- ARCH
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Prevalence of Iodine Deficiency in Remote Communities of the Central Plateau, Haiti: a Cross-sectional Study (ARCH)
- ClinicalTrials.gov ID
- NCT05275452
- Acronym / sponsor ID
- ARCH
- Conditions
- Iodine Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Notre Dame, Université Notre Dame d'Haiti UDERS de Hinche, Haiti
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School age children aged 9-13 years | – | Other: No intervention |
| Women of reproductive age aged 18-44 years | – | Other: No intervention |
Who may qualify
- Ages
- 9 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | School age children aged 9-13 years, Women of reproductive age aged 18-44 years |
Primary outcome
Urinary iodine concentration
Time frame: through study completion, estimated 2 to 3 months
iodine measured in a spot sample of urine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Rigutto, PhD principal investigator
ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Deficiency, run by Swiss Federal Institute of Technology at 1 site in Haiti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Rigutto, PhD (+41 632 43 69, jessica.rigutto@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary iodine concentration (time frame: through study completion, estimated 2 to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.