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


Original post, click here

Verified June 2017 by Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Sponsor:

Information provided by (Responsible Party):

Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT03176706

First received: June 2, 2017

Last updated: June 2, 2017

Last verified: June 2017

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.

Iodine Deficiency
Pregnancy Related
Other: no intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of Dried Blood Spot Thyroglobulin in Pregnant Women to Redefine the Range of Median Urinary Iodine Concentration That Indicates Adequate Iodine Intake

Primary Outcome Measures:

Estimated Enrollment: 3000
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Lebanese pregnant women

Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in the Lebanon.

Other: no intervention

this is a completely observational study, NO INTERVENTION

Thai pregnant women

Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Thailand.

Other: no intervention

this is a completely observational study, NO INTERVENTION

South African pregnant women

Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in South Africa.

Other: no intervention

this is a completely observational study, NO INTERVENTION

New Zealand pregnant women

Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in New Zealand.

Other: no intervention

this is a completely observational study, NO INTERVENTION

Swedish Pregnant women

Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Sweden.

Other: no intervention

this is a completely observational study, NO INTERVENTION

Peruvian pregnant women

Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Peru.

Other: no intervention

this is a completely observational study, NO INTERVENTION

Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Healthy pregnant women aged from 18 to 44 years, living since 12 months or longer in the respective country.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03176706

Swiss Federal Institute of Technology

Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT03176706     History of Changes
Other Study ID Numbers: STRIPE
Study First Received: June 2, 2017
Last Updated: June 2, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 05, 2017