NCT03215680

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

July 10, 2017

Last Update Submit

March 24, 2021

Conditions

Iodine Deficiency

Keywords

Urinary iodine concentration

Outcome Measures

Primary Outcomes (1)

  • Urinary iodine concentration

    Measured in 24h urine collections

    6 months

Secondary Outcomes (1)

  • Urinary iodine excretion

    6 months

Other Outcomes (2)

  • Urinary iodine concentration

    6 months

  • Urinary iodine excretion

    6 months

Study Arms (2)

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

ClimateOTHER

Hot and temperate climate

South African Women of Reproductive AgeTanzanian Women of Reproductive Age

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Centre of Excellence for Nutrition, Faculty of Health Science, North West University

Potchefstroom, South Africa

Location

Ministry of Health, Community Development Gender, Elderly and Children

Dar es Salaam, Tanzania

Location

Related Publications (1)

  • 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.

    PMID: 34601579DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

24h urine samples, spot urine samples, dried blood spots

MeSH Terms

Interventions

Climate

Intervention Hierarchy (Ancestors)

EnvironmentEcological and Environmental PhenomenaBiological PhenomenaAtmosphereMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Michael B Zimmermann, Prof. Dr.

    ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 12, 2017

Study Start

July 10, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 26, 2021

Record last verified: 2021-03

Locations

ZA(1)TA(1)