NCT03078140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

February 27, 2017

Last Update Submit

March 16, 2026

Conditions

Pregnancy RelatedIodine Deficiency

Outcome Measures

Primary Outcomes (1)

  • iodine status

    mean urine iodine

    at delivery

Study Arms (2)

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

TriferdineDIETARY_SUPPLEMENT

Triferdine 1 tablet daily Start from 14 weeks of gestation until delivery

Triferdine
Triferdine/Ferli-6DIETARY_SUPPLEMENT

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.

Triferdine/Ferli-6

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuntharee Traisrisilp

Chiang Mai, 50200, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 13, 2017

Study Start

May 1, 2017

Primary Completion

April 30, 2018

Study Completion

May 31, 2018

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)