Assessment of Dried Blood Spot Thyroglobulin and Urinary Iodine Concentration in Pregnant Women

Completed

• Conditions: Iodine Deficiency; Pregnancy Related
• Interventions: Other: no intervention

• Registration Number: NCT03176706
• Lead Sponsor: Swiss Federal Institute of Technology

Brief Summary

To avoid iodine deficiency and its consequences in pregnant women and their offspring, women should reach a sufficient iodine intake long before conception. To monitor iodine status, median urinary iodine concentration (UIC) is widely used in pregnant women (PW). Thyroglobulin (Tg) us another marker used to assess iodine status . In this study, urine samples as well as dried blood spots will be collected to measure UIC and Tg (as well as other hormones to define thyroid function) in PW. The results shall be used to reassess the threshold which defines iodine status in PW according to UIC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Study Start: 2017-08-09
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2900

Inclusion Criteria

1. Generally healthy
2. No major medical illness, no thyroid disease, and taking no chronic medication
3. No use of iodine containing dietary supplements
4. No use of iodine-containing X-ray /CT contrast agent or iodine containing medication within the last year
5. Aged between 18 and 44 at enrollment
6. Singleton pregnancy
7. Non-smoking
8. Residence at study site since 12 months or longer

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
South African pregnant women	no intervention	Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in South Africa.
New Zealand pregnant women	no intervention	Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in New Zealand.
Russian pregnant women	no intervention	Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Russia.
Peruvian pregnant women	no intervention	Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Peru.
Lebanese pregnant women	no intervention	Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in the Lebanon.
Thai pregnant women	no intervention	Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Thailand.
Swedish Pregnant women	no intervention	Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Sweden.

Primary Outcome Measures

Name	Time	Method
Urinary iodine concentration and Thyroglobulin concentration in pregnant women.	June 2018	Analysis of urine and blood samples to find urinary iodine concentration and Thyroglobulin concentration of each participant.

Trial Locations

Locations (1)

University of Otago; 🇳🇿 Dunedin, Otago, New Zealand