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

• Sponsor: Swiss Federal Institute of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03176706
• Collaborator: (none)
• Enrollment: 2,900
• Location: 1
• Actual Duration (Months): 24.7
• Patients Per Site Per Month: 117.4

Study Details

Study Description

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	Phase
Iodine Deficiency; Pregnancy Related	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 2900 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: Aug 9, 2017
• Actual Primary Completion Date: Aug 31, 2019
• Actual Study Completion Date: Aug 31, 2019

Arms and Interventions

Arm	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
Russian pregnant women Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Russia.	Other: no intervention; this is a completely observational study, NO INTERVENTION

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Otago	Dunedin	Otago	New Zealand	9054

Sponsors and Collaborators

• Swiss Federal Institute of Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr., Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT03176706
• Other Study ID Numbers: STRIPE
• First Posted: Jun 5, 2017
• Last Update Posted: May 13, 2020
• Last Verified: May 1, 2020

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

Study Results

No Results Posted as of May 13, 2020