Iodine Deficiency Clinical Trial
— LIONOfficial title:
Assessment of Impact of High Temperature Climate on Urinary Iodine Concentration in Women of Reproductive Age
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 |
Verified date | March 2021 |
Source | Swiss Federal Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Swiss Federal Institute of Technology | Ministry of Health, Tanzania, North-West University, South Africa |
South Africa, Tanzania,
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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