Iodine Supplement Strategies Between Routine Iodine Suppl... | NCT03078140

Studies
Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation

NCT03078140

Sponsor

Chiang Mai University

Status

Completed

Last Update Posted

Mar 18, 2026Actual

Enrollment

208Actual

Phase

Not Applicable

Conditions

Pregnancy Related
Iodine Deficiency

Interventions

Triferdine
Triferdine/Ferli-6

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Apr 30, 2018Actual

Completion Date

May 31, 2018Actual

First Submitted Date

Feb 27, 2017

First Submission Date that Met QC Criteria

Mar 7, 2017

First Posted Date

Mar 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Triferdine	Active Comparator	Triferdine 1 tablet by mouth daily. Start after 1st trimester until delivery	Dietary Supplement: Triferdine
Triferdine/Ferli-6	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Triferdine	Dietary Supplement	Triferdine 1 tablet daily Start from 14 weeks of gestation until delivery	Triferdine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
iodine status	mean urine iodine	at delivery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuntharee Traisrisilp		Chiang Mai		50200	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided