LION: Climat Impact on Urinary Iodine Concentration

Sponsor

Swiss Federal Institute of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT03215680

Collaborator

Ministry of Health, Tanzania (Other), North-West University, South Africa (Other)

363

Enrollment

Locations

17.7

Actual Duration (Months)

181.5

Patients Per Site

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Iodine Deficiency	Other: Climate

Study Design

Study Type:

Observational

Actual Enrollment :

363 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of Impact of High Temperature Climate on Urinary Iodine Concentration in Women of Reproductive Age

Actual Study Start Date :

Jul 10, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Urinary iodine concentration [6 months]
Measured in 24h urine collections

Secondary Outcome Measures

Urinary iodine excretion [6 months]
Measured in 24 h urine collections

Other Outcome Measures

Urinary iodine concentration [6 months]
Measured in spot urine samples
Urinary iodine excretion [6 months]
Measured in spot urine samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Excellence for Nutrition, Faculty of Health Science, North West University	Potchefstroom		South Africa
2	Ministry of Health, Community Development Gender, Elderly and Children	Dar es Salaam		Tanzania

Sponsors and Collaborators

Swiss Federal Institute of Technology
Ministry of Health, Tanzania
North-West University, South Africa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Michael B. Zimmermann, Prof. Dr., Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT03215680

Other Study ID Numbers:

LION

First Posted:

Jul 12, 2017

Last Update Posted:

Mar 26, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof. Michael B. Zimmermann, Prof. Dr., Swiss Federal Institute of Technology

Urinary iodine concentration

Study Results

No Results Posted as of Mar 26, 2021