Iodine DeficiencySTRIPENCT03176706
Assessment of Dried Blood Spot Thyroglobulin and Urinary Iodine Concentration in Pregnant Women
An observational study of Iodine Deficiency and Pregnancy Related, run by Swiss Federal Institute of Technology at 1 site in New Zealand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency, Pregnancy Related
- How many people
- 2,900 participants
- Where
- 1 siteNew Zealand
- Study dates
- 9 Aug 2017to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women aged from 18 to 44 years, living since 12 months or longer in the respective country.
Who may be able to join
- Generally healthy
- No major medical illness, no thyroid disease, and taking no chronic medication
- No use of iodine containing dietary supplements
- No use of iodine-containing X-ray /CT contrast agent or iodine containing medication within the last year
- Aged between 18 and 44 at enrollment
- Singleton pregnancy
- Non-smoking
- Residence at study site since 12 months or longer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Iodine Deficiency, Pregnancy Related
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this is a completely observational study, NO INTERVENTION
| Study group | Role | What they receive |
|---|---|---|
| Lebanese pregnant women | Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in the Lebanon. Receives: Other: 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. Receives: Other: 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. Receives: Other: 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. Receives: Other: 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. Receives: Other: 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. Receives: Other: 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine concentration and Thyroglobulin concentration in pregnant women.
Analysis of urine and blood samples to find urinary iodine concentration and Thyroglobulin concentration of each participant.
Measured: June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start9 Aug 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176706
- Sponsor's protocol ID
- STRIPE
- Acronym
- STRIPE
- Status last verified
- May 2020
- First submitted
- 2 Jun 2017
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03176706
- Acronym / sponsor ID
- STRIPE / STRIPE
- Conditions
- Iodine Deficiency, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,900 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Lebanese pregnant women | – | Other: no interventionPregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in the Lebanon. |
| Thai pregnant women | – | Other: no interventionPregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Thailand. |
| South African pregnant women | – | Other: no interventionPregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in South Africa. |
| New Zealand pregnant women | – | Other: no interventionPregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in New Zealand. |
| Swedish Pregnant women | – | Other: no interventionPregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Sweden. |
| Peruvian pregnant women | – | Other: no interventionPregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Peru. |
| Russian pregnant women | – | Other: no interventionPregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Russia. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women aged from 18 to 44 years, living since 12 months or longer in the respective country.
Key inclusion criteria (8 listed)
- Generally healthy
- No major medical illness, no thyroid disease, and taking no chronic medication
- No use of iodine containing dietary supplements
- No use of iodine-containing X-ray /CT contrast agent or iodine containing medication within the last year
- Aged between 18 and 44 at enrollment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionthis is a completely observational study, NO INTERVENTION | Other | Lebanese pregnant women, New Zealand pregnant women, Peruvian pregnant women, Russian pregnant women, South African pregnant women, Swedish Pregnant women, Thai pregnant women |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Deficiency and Pregnancy Related, run by Swiss Federal Institute of Technology at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary iodine concentration and Thyroglobulin concentration in pregnant women. (time frame: June 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.