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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03215680
Other study ID # LION
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 10, 2017
Est. completion date December 31, 2018

Study information

Verified date March 2021
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 363
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility - 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Climate
Hot and temperate climate

Locations

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

Sponsors (3)

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

Countries where clinical trial is conducted

South Africa,  Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Other Urinary iodine concentration Measured in spot urine samples 6 months
Other Urinary iodine excretion Measured in spot urine samples 6 months
Primary Urinary iodine concentration Measured in 24h urine collections 6 months
Secondary Urinary iodine excretion Measured in 24 h urine collections 6 months
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