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Iodine Status in Pregnant Women in Israel

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ClinicalTrials.gov Identifier: NCT03120221
Recruitment Status : Unknown
Verified January 2018 by Dr. Viviana Ostrovsky, Clalit Health Services.
Recruitment status was:  Recruiting
First Posted : April 19, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Viviana Ostrovsky, Clalit Health Services

Brief 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

Condition or disease Intervention/treatment
Iodine-Deficiency; Hypothyroidism Diagnostic Test: Urine sample for iodine measurement

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.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Iodine Status in Pregnant Women in Israel
Actual Study Start Date : July 4, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Group/Cohort Intervention/treatment
First trimester pregnant women Diagnostic Test: Urine sample for iodine measurement
Women will be required to give a urine sample for iodine measurement




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
First trimester pregnant women in Israel
Criteria

Inclusion Criteria: First trimester pregnant women with a singleton pregnancy

Exclusion Criteria:

  1. Women with a known thyroid disease treated or untreated
  2. Women who received contrast material in the year previous to the study
  3. women with any chronic disease
  4. Women who receive chronic medication not including vitamins

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): NCT03120221


Contacts
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Contact: Tal Schiller, MD 972-8-9441315 talsc1@clalit.org.il

Locations
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Israel
Women Health Service Recruiting
Ashdod, Israel
Contact: Viviana Ostrovsky, MD    972-8-7472388    vivianaos@clalit.org.il   
Contact: Shir Dar, MD    972-8-7472388    shirda@clalit.org.il   
Women Health Center Not yet recruiting
Tel Aviv, Israel
Contact: Arnon Agmon, MD    972-3-7503140    ArnonAg@clalit.org.il   
Sponsors and Collaborators
Clalit Health Services
Investigators
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Principal Investigator: Viviana Ostrovsky, MD Clalit Health Services
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Responsible Party: Dr. Viviana Ostrovsky, Principal Investigator, Senior Physician, Endocrinology Department, Clalit Health Services
ClinicalTrials.gov Identifier: NCT03120221    
Other Study ID Numbers: 0092-16-COM2
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Viviana Ostrovsky, Clalit Health Services:
Pregnancy
Iodine deficiency
Thyroid
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases