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

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ClinicalTrials.gov Identifier: NCT03176706
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, 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.

Condition or disease Intervention/treatment
Iodine Deficiency Pregnancy Related Other: no intervention

Study Type : Observational
Estimated Enrollment : 3000 participants
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
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes
Drug Information available for: Iodine

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Urinary iodine concentration and Thyroglobulin concentration in pregnant women. [ Time Frame: June 2018 ]
    Analysis of urine and blood samples to find urinary iodine concentration and Thyroglobulin concentration of each participant.



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant women aged from 18 to 44 years, living since 12 months or longer in the respective country.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176706


Contacts
Contact: Sandra M Hunziker, MSc 044 632 80 97 sandra.hunziker@hest.ethz.ch
Contact: Michael B Zimmermann, Prof. Dr. 044 632 86 57 michael.zimmermann@hest.ethz.ch

Locations
New Zealand
University of Otago Recruiting
Dunedin, Otago, New Zealand, 9054
Contact: Sheila Skeaff, associate professor    +6434797944    sheila.skeaff@otago.ac.nz   
Sponsors and Collaborators
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
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: June 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