Pregnancy RelatedNCT03078140
Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation
A study testing Triferdine and Triferdine/Ferli-6 in people with Pregnancy Related and Iodine Deficiency, run by Chiang Mai University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Related, Iodine Deficiency
- What is being tested?
- Triferdine and Triferdine/Ferli-6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- first visit for antenatal care in the first trimester
- singleton pregnancy
- delivered at Maharaj Nakorn Chiangmai Hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pregnancy Related, Iodine Deficiency
- Being tested
- Triferdine, Triferdine/Ferli-6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriferdineDietary supplement
Triferdine 1 tablet daily Start from 14 weeks of gestation until delivery
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.
| Study group | Role | What they receive |
|---|---|---|
| Triferdine | Active comparator | Triferdine 1 tablet by mouth daily. Start after 1st trimester until delivery Receives: 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 Receives: Dietary Supplement: Triferdine/Ferli-6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
iodine status
mean urine iodine
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 May 2017
- Primary completion30 Apr 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuntharee Traisrisilp, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078140
- Sponsor's protocol ID
- 4298
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2017
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study to Compare Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation
- ClinicalTrials.gov ID
- NCT03078140
- Acronym / sponsor ID
- 4298
- Conditions
- Pregnancy Related, Iodine Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triferdine | Active comparator | Dietary Supplement: TriferdineTriferdine 1 tablet by mouth daily. Start after 1st trimester until delivery |
| Triferdine/Ferli-6 | Active comparator | Dietary Supplement: Triferdine/Ferli-6Triferdine or ferli-6 1 tablet by mouth daily base on iodine status. The supplement will give after 1st trimester until delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- first visit for antenatal care in the first trimester
- singleton pregnancy
- delivered at Maharaj Nakorn Chiangmai Hospital
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriferdineTriferdine 1 tablet daily Start from 14 weeks of gestation until delivery | Dietary supplement | Triferdine |
| Triferdine/Ferli-6For 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. | Dietary supplement | Triferdine/Ferli-6 |
Primary outcome
iodine status
Time frame: at delivery
mean urine iodine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triferdine and Triferdine/Ferli-6 in people with Pregnancy Related and Iodine Deficiency, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iodine status (time frame: at delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.