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NCT03120221 Clinical Trial

Iodine Status in Pregnant Women in Israel

Iodine-Deficiency; Hypothyroidism Clinical Trial

Official title:
Iodine Status in Pregnant Women in Israel

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03120221
Other study ID # 0092-16-COM2
Secondary ID
Status Recruiting
Phase N/A
First received April 1, 2017
Last updated January 31, 2018
Start date July 4, 2017
Est. completion date December 31, 2018

Study information
Verified date January 2018
Source Clalit Health Services
Contact Tal Schiller, MD
Phone 972-8-9441315
Email talsc1@clalit.org.il
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Urine sample for iodine measurement
Women will be required to give a urine sample for iodine measurement

Locations
Country Name City State
Israel Women Health Service Ashdod
Israel Women Health Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 1 year
Primary 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 1 year
Primary 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. 1 year