Iodine Status in Pregnant Women in Israel

January 31, 2018 updated by: Dr. Viviana Ostrovsky, Clalit Health Services
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashdod, Israel
      • Tel Aviv, Israel
        • Not yet recruiting
        • Women Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

First trimester pregnant women in Israel

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clalit Health Services

Investigators

  • Principal Investigator: Viviana Ostrovsky, MD, Clalit Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

April 1, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 19, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0092-16-COM2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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