Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation

October 9, 2018 updated by: Kuntharee Traisrisilp, ChaingMai University

The Study to Compare Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation

Pregnant women who attend at our antenatal clinic will random to 2 groups. First will receive routine iodine supplementation. The other will receive iodinated pill or only iron supplementation base on their urine iodine status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

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

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Kuntharee Traisrisilp

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • first visit for antenatal care in the first trimester
  • singleton pregnancy
  • delivered at Maharaj Nakorn Chiangmai Hospital

Exclusion Criteria:

  • thyroid disease which diagnosed before pregnancy or currently
  • history of thyroid gland surgery or iodine ablation therapy
  • received iodine supplement before pregnancy
  • received any medication for thyroid disease treatment, within 6 weeks postpartum women or breast feeding period
  • family history of thyroid disease
  • having underlying disease or contraindication which cannot received iodine supplement
  • loss follow-up or incomplete data.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Triferdine
Triferdine 1 tablet by mouth daily. Start after 1st trimester until delivery
Dietary supplement: Triferdine
Triferdine 1 tablet daily Start from 14 weeks of gestation until delivery
Active Comparator: Triferdine/Ferli-6
Triferdine or ferli-6 1 tablet by mouth daily base on iodine status. The supplement will give after 1st trimester until delivery
Dietary supplement: Triferdine/Ferli-6

For the participants assigned to this group, urine iodine level will be checked first.

For participants with normal urine iodine level, Ferli-6 1 tab daily will be given.

For those with low urine iodine level, Triferdine 1 tab daily will be given. Medication will be started from 14 weeks of gestation until delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iodine status
Time Frame: at delivery
mean urine iodine
at delivery

Collaborators and Investigators

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

Sponsor

ChaingMai University

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)

May 1, 2017

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 4298

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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