Climat Impact on Urinary Iodine Concentration | NCT03215680

Studies
Climat Impact on Urinary Iodine Concentration

NCT03215680

Sponsor

Swiss Federal Institute of Technology

Status

Completed

Last Update Posted

Mar 26, 2021Actual

Enrollment

363Actual

Phase

Not provided

Conditions

Iodine Deficiency

Interventions

Climate

Countries

South Africa
Tanzania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jul 10, 2017

First Submission Date that Met QC Criteria

Jul 10, 2017

First Posted Date

Jul 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2021

Last Update Posted Date

Mar 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Michael B. Zimmermann, Prof. Dr., Swiss Federal Institute of TechnologyPrincipal Investigator

Lead Sponsor

Swiss Federal Institute of TechnologyOTHER

Collaborators

Name	Class
Ministry of Health, Tanzania	OTHER_GOV
North-West University, South Africa	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

363Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tanzanian Women of Reproductive Age		Healthy women of reproductive age living in Tanzania in an area with hot and temperate climate	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	Other: Climate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Climate	Other	Hot and temperate climate	South African Women of Reproductive Age Tanzanian Women of Reproductive Age

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Healthy women between 18 and 49 years of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael B Zimmermann, Prof. Dr.	ETH Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre of Excellence for Nutrition, Faculty of Health Science, North West University		Potchefstroom			South Africa

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34601579	Derived	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.

ID	Term
D004777	Environment
D055669	Ecological and Environmental Phenomena
D001686	Biological Phenomena
D001272	Atmosphere