Iodine DeficiencyLIONNCT03215680
Climat Impact on Urinary Iodine Concentration
An observational study of Iodine Deficiency, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
Trial summary
Urinary iodine concentration (UIC) is the recommended biomarker of iodine status in populations. Yet, the influence of climate on UIC remains unclear. Hot climate may reduce urine volume and consequently increase UIC independent of iodine status. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- What is being tested?
- Climate
- How many people
- 363 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jul 2017to 31 Dec 2018
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women between 18 and 49 years of age
- Female
- Non-pregnant and non-lactating
- General good health, assessed by no reported treatment for chronic disease
- Non-smoking
- No known history of major medical illnesses or thyroid dysfunction as well as gastrointestinal or metabolic disorders and taking no chronic medication
- Residence at the respective study site for 12 months or longer and no plans of moving away during the study year.
- No use of iodine containing dietary supplements during the last 6 months
- No use of X-ray / CT contrast agent or iodine containing medication within the last year
- No use of iodine containing disinfectants during the last 6 months
- Participants should be between 18 and 49 years at date of enrollment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
Centre of Excellence for Nutrition, Faculty of Health Science, North West University
Potchefstroom
Tanzania1 site
Ministry of Health, Community Development Gender, Elderly and Children
Dar es Salaam
About this study
Official title: Assessment of Impact of High Temperature Climate on Urinary Iodine Concentration in Women of Reproductive Age
Urinary iodine concentration (UIC) is the recommended biomarker of iodine status in populations. Yet, the influence of climate on UIC remains unclear. Hot climate may reduce urine volume and consequently increase UIC independent of iodine status. This could lead to an overestimation of population iodine intake, thus masking iodine deficiency in vulnerable groups.
In this longitudinal observational cohort study in women of reproductive age we will collect 24h and spot urine samples in the summer and winter season. The influence of high temperature climates on UIC, measured and estimated urinary iodine excretion will be estimated.
- Conditions
- Iodine Deficiency
- Being tested
- Climate
- Keywords
- Urinary iodine concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClimateOther
Hot and temperate climate
| Study group | Role | What they receive |
|---|---|---|
| Tanzanian Women of Reproductive Age | Healthy women of reproductive age living in Tanzania in an area with hot and temperate climate Receives: Other: Climate | |
| South African Women of Reproductive Age | Healthy women of reproductive age living in South Africa in an area with hot and temperate climate Receives: Other: Climate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine concentration
Measured in 24h urine collections
Measured: 6 months
Secondary outcomes (1)
Urinary iodine excretion
Measured in 24 h urine collections
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start10 Jul 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Tanzania, North-West University, South Africa
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael B Zimmermann, Prof. Dr., Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215680
- Sponsor's protocol ID
- LION
- Acronym
- LION
- Status last verified
- Mar 2021
- First submitted
- 10 Jul 2017
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arns-Glaser L, Zandberg L, Assey VD, Baumgartner J, Abdallah F, Galetti V, Dary O, Zimmermann MB, Andersson M. Seasonal effects on urinary iodine concentrations in women of reproductive age: An observational study in Tanzania and South Africa. Am J Clin Nutr. 2022 Jan 11;115(1):298-309. doi: 10.1093/ajcn/nqab327.
PubMed 34601579
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Impact of High Temperature Climate on Urinary Iodine Concentration in Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT03215680
- Acronym / sponsor ID
- LION / LION
- Conditions
- Iodine Deficiency
- Keywords
- Urinary iodine concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Ministry of Health, Tanzania, North-West University, South Africa
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Jul 2017 (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.
Urinary iodine concentration (UIC) is the recommended biomarker of iodine status in populations. Yet, the influence of climate on UIC remains unclear. Hot climate may reduce urine volume and consequently increase UIC independent of iodine status. This could lead to an overestimation of population iodine intake, thus masking iodine deficiency in vulnerable groups.
In this longitudinal observational cohort study in women of reproductive age we will collect 24h and spot urine samples in the summer and winter season. The influence of high temperature climates on UIC, measured and estimated urinary iodine excretion will be estimated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tanzanian Women of Reproductive Age | – | Other: ClimateHealthy women of reproductive age living in Tanzania in an area with hot and temperate climate |
| South African Women of Reproductive Age | – | Other: ClimateHealthy women of reproductive age living in South Africa in an area with hot and temperate climate |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women between 18 and 49 years of age
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 |
|---|---|---|
| ClimateHot and temperate climate | Other | South African Women of Reproductive Age, Tanzanian Women of Reproductive Age |
Primary outcome
Urinary iodine concentration
Time frame: 6 months
Measured in 24h urine collections
1 secondary outcome
Urinary iodine excretion
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Derived from this study: PubMed 34601579Arns-Glaser L, Zandberg L, Assey VD, Baumgartner J, Abdallah F, Galetti V, Dary O, Zimmermann MB, Andersson M. Seasonal effects on urinary iodine concentrations in women of reproductive age: An observational study in Tanzania and South Africa. Am J Clin Nutr. 2022 Jan 11;115(1):298-309. doi: 10.1093/ajcn/nqab327.
- Individual participant dataSharing planned: Undecided
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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.
Michael B Zimmermann, Prof. Dr. principal investigator
ETH Zurich
2 sites in 2 countries: 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 2 sites in 2 countries.
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: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Tanzania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary iodine concentration (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03215680, which also lists 1 linked publication.
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 26 Mar 2021.