Climat Impact on Urinary Iodine Concentration (LION)

March 24, 2021 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

363

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Potchefstroom, South Africa
        • Centre of Excellence for Nutrition, Faculty of Health Science, North West University
  • Tanzania
      • Dar es Salaam, Tanzania
        • Ministry of Health, Community Development Gender, Elderly and Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy women between 18 and 49 years of age

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tanzanian Women of Reproductive Age
Healthy women of reproductive age living in Tanzania in an area with hot and temperate climate
Other: Climate
Hot and temperate climate
South African Women of Reproductive Age
Healthy women of reproductive age living in South Africa in an area with hot and temperate climate
Other: Climate
Hot and temperate climate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary iodine concentration
Time Frame: 6 months
Measured in 24h urine collections
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary iodine excretion
Time Frame: 6 months
Measured in 24 h urine collections
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary iodine concentration
Time Frame: 6 months
Measured in spot urine samples
6 months
Urinary iodine excretion
Time Frame: 6 months
Measured in spot urine samples
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

North-West University, South Africa
Ministry of Health, Tanzania

Investigators

  • Principal Investigator: Michael B Zimmermann, Prof. Dr., ETH Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 10, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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