Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation
The Study to Compare Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Chiang Mai, Thailand, 50200
- Kuntharee Traisrisilp
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Triferdine
Triferdine 1 tablet by mouth daily.
Start after 1st trimester until delivery
|
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
|
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
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
iodine status
Time Frame: at delivery
|
mean urine iodine
|
at delivery
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 4298
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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