Iodine-Deficiency; HypothyroidismNCT03120221
Iodine Status in Pregnant Women in Israel
An observational study of Iodine-Deficiency; Hypothyroidism, run by Clalit Health Services at 2 sites in Israel.
Trial summary
Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women. Thus, screening first trimester healthy pregnant women for iodine status is of clinical value for mother and child as iodine deficiency might have implications on thyroid function as well as pregnancy outcomes Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine-Deficiency; Hypothyroidism
- What is being tested?
- Urine sample for iodine measurement
- How many people
- 160 participants
- Where
- 2 sitesIsrael
- Study dates
- 4 Jul 2017to 31 Dec 2018
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: First trimester pregnant women in Israel
Who may be able to join
None listed.
Who cannot join
- Women with a known thyroid disease treated or untreated
- Women who received contrast material in the year previous to the study
- women with any chronic disease
- Women who receive chronic medication not including vitamins
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Women Health Service
Ashdod
Viviana Ostrovsky, MD, 972-8-7472388, vivianaos@clalit.org.il
Shir Dar, MD, 972-8-7472388, shirda@clalit.org.il
- Not yet recruiting
Women Health Center
Tel Aviv
Arnon Agmon, MD, 972-3-7503140, ArnonAg@clalit.org.il
About this study
Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women. Thus, screening first trimester healthy pregnant women for iodine status is of clinical value for mother and child as iodine deficiency might have implications on thyroid function as well as pregnancy outcomes
Read the detailed description
New emerging data suggest pregnant women in Israel are iodine deficient in the first trimester of pregnancy. This is of major concern as first trimester iodine sufficiency is critical for the development of the fetal brain. Our aim is to evaluate iodine consumption in first trimester pregnant women in Israel through dietary questioners, Urinary iodine samples and thyroid functions test assessed through blood samples. All data will be analyzed in a central lab.
- Conditions
- Iodine-Deficiency; Hypothyroidism
- Being tested
- Urine sample for iodine measurement
- Keywords
- Pregnancy, Iodine deficiency, Thyroid
- Medical subject headings
- Hypothyroidism, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine sample for iodine measurementDiagnostic test
Women will be required to give a urine sample for iodine measurement
| Study group | Role | What they receive |
|---|---|---|
| First trimester pregnant women | Not described Receives: Diagnostic Test: Urine sample for iodine measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of average iodine consumption in food
Iodine consumption will be evaluated trough detailed food questionnaires. Data will be quantified and reported in micrograms per day
Measured: 1 year
Evaluation of urinary iodine concentration
Women will give a spot urine sample for urinary iodine concentration measurement. All data will be analyzed and reported in micrograms/L. Data obtained will be compared to World Health Organization requirements
Measured: 1 year
Thyroid function test measurement
Thyroid function will be evaluated through blood tests in the first trimester of pregnancy. Data will be analyzed in accordance with local guidelines.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start4 Jul 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine-Deficiency; HypothyroidismStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Viviana Ostrovsky, Clalit Health Services
- Investigators
- Viviana Ostrovsky, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120221
- Sponsor's protocol ID
- 0092-16-COM2
- Status last verified
- Jan 2018
- First submitted
- 1 Apr 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Status in Pregnant Women in Israel
- ClinicalTrials.gov ID
- NCT03120221
- Acronym / sponsor ID
- 0092-16-COM2
- Conditions
- Iodine-Deficiency; Hypothyroidism
- Keywords
- Pregnancy, Iodine deficiency, Thyroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 19 Apr 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.
Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women. Thus, screening first trimester healthy pregnant women for iodine status is of clinical value for mother and child as iodine deficiency might have implications on thyroid function as well as pregnancy outcomes
Detailed description
New emerging data suggest pregnant women in Israel are iodine deficient in the first trimester of pregnancy. This is of major concern as first trimester iodine sufficiency is critical for the development of the fetal brain. Our aim is to evaluate iodine consumption in first trimester pregnant women in Israel through dietary questioners, Urinary iodine samples and thyroid functions test assessed through blood samples. All data will be analyzed in a central lab.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First trimester pregnant women | – | Diagnostic Test: Urine sample for iodine measurement |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- First trimester pregnant women in Israel
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Women with a known thyroid disease treated or untreated
- Women who received contrast material in the year previous to the study
- women with any chronic disease
- Women who receive chronic medication not including vitamins
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 |
|---|---|---|
| Urine sample for iodine measurementWomen will be required to give a urine sample for iodine measurement | Diagnostic test | First trimester pregnant women |
Primary outcome
Evaluation of average iodine consumption in food
Time frame: 1 year
Iodine consumption will be evaluated trough detailed food questionnaires. Data will be quantified and reported in micrograms per day
Evaluation of urinary iodine concentration
Time frame: 1 year
Women will give a spot urine sample for urinary iodine concentration measurement. All data will be analyzed and reported in micrograms/L. Data obtained will be compared to World Health Organization requirements
Thyroid function test measurement
Time frame: 1 year
Thyroid function will be evaluated through blood tests in the first trimester of pregnancy. Data will be analyzed in accordance with local guidelines.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Iodine-Deficiency; Hypothyroidism
Active, not recruitingObservational study
Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region
Iodine Deficiency, Thyroid
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.
Viviana Ostrovsky, MD principal investigator
Clalit Health Services
2 sites 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; Hypothyroidism, run by Clalit Health Services at 2 sites in Israel.
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 0 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tal Schiller, MD (972-8-9441315, talsc1@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of average iodine consumption in food (time frame: 1 year). The study lists 3 primary outcomes in all. 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 1 Feb 2018.