Thyroid AbnormalitiesPhase 4LIGHTNCT06653907
Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU/L-upper Limit of Reference Range） and Negative Thyroid Peroxidase Antibody
A Phase 4 study testing Levothyroxine Sodium (LT4) Tablets in people with Thyroid Abnormalities and Pregnant Woman, run by Yang ZHANG at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if levothyroxine (L-T4) works to treat pregnant women with TSH 2.5 mIU/L-the upper limit of reference range (ULRR) of pregnancy and TPOAb-negative. It will also learn about the safety of L-T4. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Thyroid Abnormalities, Pregnant Woman, Pregnancy Outcomes
- What is being tested?
- Levothyroxine Sodium (LT4) Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2024to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women of childbearing age（18-45 years old）, natural pregnancy, singleton pregnancy.
- Measure thyroid related indexes within 8 weeks of pregnancy: TSH 2.5mIU/L-ULRR, FT4 is normal and TPOAb negativity.
- Willing to sign an informed consent form.
Who cannot join
- History of recurrent miscarriage (≥3 times).
- Assisted reproduction (artificial insemination, in vitro fertilization and embryo transfer);
- Suffer from diseases that seriously affect pregnancy outcome, including hypertension, diabetes, heart disease, liver and kidney dysfunction, etc.
- Failure of vital organs.
- Except autoimmune thyroid disease，suffer from other autoimmune diseases.
- Thyroid diseases (including hyperthyroidism, thyroid cancer, thyroid amyloidosis and other extensive intrathyroidal diseases, current subacute thyroiditis, iodine-deficiency endemic goiter, thyroidectomy or 131I treatment, previous thyroid Ultrasound prompts diffuse thyroid disease, etc.).
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- Use of thyroid-related drugs (lithium carbonate, thioureas, sulfonamides, sodium para-amino salicylate, potassium perchlorate, phenylbutazone, sulfate, tyrosine kinase inhibitor, etc.) during screening and affect thyroid Functional testing drugs. (Including glucocorticoids, metoclopramide, propranolol, amiodarone, sodium valproate, etc.)
- Secondary hypothyroidism or central hypothyroidism. (Including pituitary tumors, surgery, radiotherapy, lymphocytic hypophysitis, etc.)
- L-T4 allergy.
- Unwilling to sign an informed consent.
- Other clinicians judged that they are not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fourth hospital of Shijiazhuang city
Shijiazhuang, Heibei, 050011
Guohua Zhang, Professor, 0086031189927628, zghh_456@163.com
About this study
Official title: Randomized Control Study of Levothyroxine Intervention in Pregnant Women with Thyroid Stimulating Hormone Between 2.5 MIU/L and Upper Limit of Reference Range and Negative Thyroid Peroxidase Antibody
The goal of this clinical trial is to learn if levothyroxine (L-T4) works to treat pregnant women with TSH 2.5 mIU/L-the upper limit of reference range (ULRR) of pregnancy and TPOAb-negative. It will also learn about the safety of L-T4. The main quesitons the investigator want to answer are:
- Will L-T4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants?
- What medical issues do participants have when taking L-T4 during pregnancy? -Investigators will compare L-T4 with placebo (a substance with a similar appearance without medication) to see if L-T4 could reduce miscarriage rates
Read more
Participants should:
- Take L-T4 or placebo during the whole pregnancy.
- Visit the hospital once every 6-8 weeks during pregnancy for checkups and tests
- Keep a diary of their pregncny complications and daily record of L-T4 or placebo intake.
- Visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum.
- Conditions
- Thyroid Abnormalities, Pregnant Woman, Pregnancy Outcomes
- Being tested
- Levothyroxine Sodium (LT4) Tablets, Placebo
- Keywords
- TSH, TPOAb, pregnant women, levothyroxine, outcome
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine Sodium (LT4) TabletsDrug
Participants in our study will determine the dosage of L-T4 based on their weight (BW):
- BW ≥50kg: Starting with a daily dose of 1 tablet;
- BW < 50kg: Starting with a daily dose of half a tablet.
At 12 weeks, 18-20 weeks, 24-26 weeks, and 34-36 weeks of gestation, the serum TSH, FT3, and FT4 will be measured, and investigator will adjust dosage according to TSH:
- When TSH > ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up;
- When TSH at 2.5mIU/L-ULRR, add 1/4 tablet of medictaion;
- When TSH at LLRR -2.5mIU/L, maintain the original dose;
- When TSH <LLRR, reduce 1/4 tablets of medictaion.
- If TSH continues to be lower than LLRR after discontinuation, investigator will measure FT4, TRAb and other indicators to determine if it is clinical hyperthyroidism. If so, antithyroid drugs will administered according to guidelines. Participants will stop all trial medictaion after delivery.
PlaceboDrug
Participants in our study will determine the dosage of placebo based on their weight (BW):
- BW ≥50kg: Starting with a daily dose of 1 tablet;
- BW < 50kg: Starting with a daily dose of half a tablet.
At 12 weeks, 18-20 weeks, 24-26 weeks, and 34-36 weeks of gestation, the serum TSH, FT3, and FT4 will be measured, and investigator will adjust dosage according to TSH:
- When TSH > ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up;
- When TSH at 2.5mIU/L-ULRR, add 1/4 tablet of medictaion;
- When TSH at LLRR -2.5mIU/L, maintain the original dose;
- When TSH <LLRR, reduce 1/4 tablets of medictaion.
- If TSH continues to be lower than LLRR after discontinuation, investigator will measure FT4, TRAb and other indicators to determine if it is clinical hyperthyroidism. If so, antithyroid drugs will administered according to guidelines. Participants will stop all trial medictaion after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an oral placebo group during pregnancy. Participants in our study will determine the dosage of medication based on their weight. Receives: Drug: Placebo |
| Levothyroxine | Active comparator | The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an active comparator group of oral Levothyroxine (L-T4) during pregnancy. Participants in our study will determine the dosage of medication based on their weight. Receives: Drug: Levothyroxine Sodium (LT4) Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fetal loss
- Abortion: Ultrasound examination shows no embryo sac or only empty sac, no fetal heart or bud development.
- Intrauterine fetal death: Fetal death in utero at 20 weeks or more of pregnancy.
- Stillbirth: Death at birth over 28 weeks of pregnancy.
- Neonatal death: Newborns die within 7 days.
Measured: From enrollment to the end of treatment at 40 weeks
Secondary outcomes (18)
Fetal loss rates and reasons within 12 weeks of pregnancy.
Measured: From enrollment to the end of treatment at 12 weeks
Fetal loss rates and reasons within 24 weeks of pregnancy.
Measured: From enrollment to the end of treatment at 24 weeks
Fetal loss rates and reasons within 28 weeks of pregnancy.
Measured: From enrollment to the end of treatment at 28 weeks
Fetal loss rates and reasons within 34 weeks of pregnancy.
Measured: From enrollment to the end of treatment at 34 weeks
Rate of cesarean section
Measured: From enrollment to the end of treatment at 40 weeks
Gestational week of delivery
Measured: From enrollment to the end of treatment at 40 weeks
Number of Participants requiring treatments for preventing miscarriage
Drugs, cervical cerclage, etc.
Measured: From enrollment to the end of treatment at 40 weeks
Rate of hyperemesis gravidarum
Measured: From enrollment to the end of treatment at 40 weeks
Rate of gestational diabetes
GDM:
- FPG≥5.1mmol/L,<7.0mmol/L during the first prenatal examination
- During weeks 24-28, if blood glucose was elevated in a 75 g oral glucose tolerance test according to the criteria of International Association of the Diabetes and Pregnancy Study Groups; 0 hour ≥5.1 mmol/L, 1 hour ≥10.0 mmol/L, 2 hours ≥8.5 mmol/L Satisfy any of the above criteria to diagnose GDM
Measured: From enrollment to the end of treatment at 40 weeks
Rate of hypertensive disorders of pregnancy
Hypertensive disorders of pregnancy include: hypertension during pregnancy, preeclampsia and eclampsia
Measured: From enrollment to the end of treatment at 40 weeks
Rate of early preterm delivery
28 weeks ≤ gestational week of delivery <34 weeks;
Measured: From enrollment to the end of treatment at 34 weeks
Rate of late preterm delivery
34 weeks ≤ delivery gestational week <37 weeks
Measured: From enrollment to the end of treatment at 37 weeks
Rate of intrauterine growth restriction
Measured: From enrollment to the end of treatment at 40 weeks
Rate of abruption of placenta
Measured: From enrollment to the end of treatment at 40 weeks
Rate of dystocia
Dystocia: fetus delivery is difficult, requiring assisted delivery or cesarean section
Measured: From enrollment to the end of treatment at 40 weeks
Rate of macrosomia
Macrosomia: the newborn's birth weight >=4000 g
Measured: From enrollment to the end of newborn delivery date.
Rate of low birth weight
Low birth weight: the newborn's birth weight <2500 g
Measured: From enrollment to the end of newborn delivery date.
Incidence of composite adverse outcomes
The occurrence of one or more of these above events (maternal and fetal) was defined as the occurrence of prenatal composite adverse outcomes.
Measured: From enrollment to the end of treatment at 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start25 Oct 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid AbnormalitiesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang ZHANG
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Institute for Family Planning, China, The Fourth Hospital of Shijiazhuang
- Responsible party
- Sponsor-investigator, Yang ZHANG, Peking University First Hospital
- Investigators
- Ying Gao, Professor, Study chair, Endocrinology Department of Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653907
- Sponsor's protocol ID
- 20230099
- Other IDs
- 2021CR29
- Acronym
- LIGHT
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the clinical information of the participants and the primary outcome data of the LIGHT study will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study of Levothyroxine Intervention in Pregnant Women with Thyroid Stimulating Hormone Between 2.5 MIU/L and Upper Limit of Reference Range and Negative Thyroid Peroxidase Antibody
- ClinicalTrials.gov ID
- NCT06653907
- Acronym / sponsor ID
- LIGHT / 20230099
- Conditions
- Thyroid Abnormalities, Pregnant Woman, Pregnancy Outcomes
- Keywords
- TSH, TPOAb, pregnant women, levothyroxine, outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yang ZHANGUniversity, hospital or other
- Collaborators
- National Research Institute for Family Planning, China, The Fourth Hospital of Shijiazhuang
- Study start
- 25 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 22 Oct 2024 (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.
The goal of this clinical trial is to learn if levothyroxine (L-T4) works to treat pregnant women with TSH 2.5 mIU/L-the upper limit of reference range (ULRR) of pregnancy and TPOAb-negative. It will also learn about the safety of L-T4. The main quesitons the investigator want to answer are:
- Will L-T4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants?
- What medical issues do participants have when taking L-T4 during pregnancy? -Investigators will compare L-T4 with placebo (a substance with a similar appearance without medication) to see if L-T4 could reduce miscarriage rates
Participants should:
- Take L-T4 or placebo during the whole pregnancy.
- Visit the hospital once every 6-8 weeks during pregnancy for checkups and tests
- Keep a diary of their pregncny complications and daily record of L-T4 or placebo intake.
- Visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an oral placebo group during pregnancy. Participants in our study will determine the dosage of medication based on their weight. |
| Levothyroxine | Active comparator | Drug: Levothyroxine Sodium (LT4) TabletsThe target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an active comparator group of oral Levothyroxine (L-T4) during pregnancy. Participants in our study will determine the dosage of medication based on their weight. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women of childbearing age（18-45 years old）, natural pregnancy, singleton pregnancy.
- Measure thyroid related indexes within 8 weeks of pregnancy: TSH 2.5mIU/L-ULRR, FT4 is normal and TPOAb negativity.
- Willing to sign an informed consent form.
Key exclusion criteria (11 listed)
- History of recurrent miscarriage (≥3 times).
- Assisted reproduction (artificial insemination, in vitro fertilization and embryo transfer);
- Suffer from diseases that seriously affect pregnancy outcome, including hypertension, diabetes, heart disease, liver and kidney dysfunction, etc.
- Failure of vital organs.
- Except autoimmune thyroid disease，suffer from other autoimmune diseases.
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 |
|---|---|---|
| Levothyroxine Sodium (LT4) TabletsParticipants in our study will determine the dosage of L-T4 based on their weight (BW): 1. BW ≥50kg: Starting with a daily dose of 1 tablet; 2. BW < 50kg: Starting with a daily dose of half a tablet. At 12 weeks, 18-20 weeks, 24-26 weeks, and 34-36 weeks of gestation, the serum TSH, FT3, and FT4 will be measured, and investigator will adjust dosage according to TSH: 1. When TSH > ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up; 2. When TSH at 2.5mIU/L-ULRR, add 1/4 tablet of medictaion; 3. When TSH at LLRR -2.5mIU/L, maintain the original dose; 4. When TSH <LLRR, reduce 1/4 tablets of medictaion. 5. If TSH continues to be lower than LLRR after discontinuation, investigator will measure FT4, TRAb and other indicators to determine if it is clinical hyperthyroidism. If so, antithyroid drugs will administered according to guidelines. Participants will stop all trial medictaion after delivery. | Drug | Levothyroxine |
| PlaceboParticipants in our study will determine the dosage of placebo based on their weight (BW): 1. BW ≥50kg: Starting with a daily dose of 1 tablet; 2. BW < 50kg: Starting with a daily dose of half a tablet. At 12 weeks, 18-20 weeks, 24-26 weeks, and 34-36 weeks of gestation, the serum TSH, FT3, and FT4 will be measured, and investigator will adjust dosage according to TSH: 1. When TSH > ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up; 2. When TSH at 2.5mIU/L-ULRR, add 1/4 tablet of medictaion; 3. When TSH at LLRR -2.5mIU/L, maintain the original dose; 4. When TSH <LLRR, reduce 1/4 tablets of medictaion. 5. If TSH continues to be lower than LLRR after discontinuation, investigator will measure FT4, TRAb and other indicators to determine if it is clinical hyperthyroidism. If so, antithyroid drugs will administered according to guidelines. Participants will stop all trial medictaion after delivery. | Drug | Placebo |
Primary outcome
Rate of fetal loss
Time frame: From enrollment to the end of treatment at 40 weeks
* Abortion: Ultrasound examination shows no embryo sac or only empty sac, no fetal heart or bud development. * Intrauterine fetal death: Fetal death in utero at 20 weeks or more of pregnancy. * Stillbirth: Death at birth over 28 weeks of pregnancy. * Neonatal death: Newborns die within 7 days.
18 secondary outcomes
Fetal loss rates and reasons within 12 weeks of pregnancy.
Time frame: From enrollment to the end of treatment at 12 weeks
Fetal loss rates and reasons within 24 weeks of pregnancy.
Time frame: From enrollment to the end of treatment at 24 weeks
Fetal loss rates and reasons within 28 weeks of pregnancy.
Time frame: From enrollment to the end of treatment at 28 weeks
Fetal loss rates and reasons within 34 weeks of pregnancy.
Time frame: From enrollment to the end of treatment at 34 weeks
Rate of cesarean section
Time frame: From enrollment to the end of treatment at 40 weeks
Gestational week of delivery
Time frame: From enrollment to the end of treatment at 40 weeks
Number of Participants requiring treatments for preventing miscarriage
Time frame: From enrollment to the end of treatment at 40 weeks
Rate of hyperemesis gravidarum
Time frame: From enrollment to the end of treatment at 40 weeks
Rate of gestational diabetes
Time frame: From enrollment to the end of treatment at 40 weeks
Rate of hypertensive disorders of pregnancy
Time frame: From enrollment to the end of treatment at 40 weeks
Rate of early preterm delivery
Time frame: From enrollment to the end of treatment at 34 weeks
Rate of late preterm delivery
Time frame: From enrollment to the end of treatment at 37 weeks
Rate of intrauterine growth restriction
Time frame: From enrollment to the end of treatment at 40 weeks
Rate of abruption of placenta
Time frame: From enrollment to the end of treatment at 40 weeks
Rate of dystocia
Time frame: From enrollment to the end of treatment at 40 weeks
Rate of macrosomia
Time frame: From enrollment to the end of newborn delivery date.
Rate of low birth weight
Time frame: From enrollment to the end of newborn delivery date.
Incidence of composite adverse outcomes
Time frame: From enrollment to the end of treatment at 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Yes. the clinical information of the participants and the primary outcome data of the LIGHT study will be shared
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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.
Ying Gao, Professor study chair
Endocrinology Department of Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine Sodium (LT4) Tablets in people with Thyroid Abnormalities and Pregnant Woman, run by Yang ZHANG at 1 site in China.
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 11 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: opening soon, as of the sponsor's last update on 23 Oct 2024. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Zhang, Doctor (008601083575103, emilyzy14@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fetal loss (time frame: From enrollment to the end of treatment at 40 weeks). 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 23 Oct 2024.