Pregnancy RelatedNCT03115515
Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy
A study testing levothyroxine in people with Pregnancy Related and Thyroid, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
In women who require thyroid hormone replacement medication, the investigators will compare 2 ways to adjust thyroid medication during pregnancy to determine superiority in maintaining optimal blood levels of thyroid hormone. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Thyroid
- What is being tested?
- levothyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female between ages of 18-45 who takes thyroid hormone replacement medicine AND pregnant or plan to become pregnant in the near future.
Who cannot join
- Males
- Younger than 18 or older than 45 years old
- More than 10 weeks pregnant at enrollment
- Iodine deficient
- Pregnant with more than one baby (i.e., twins, triplets, etc.)
- NOT taking thyroid hormone medicine before becoming pregnant
- Levels of thyroid hormone in blood have been too low or too high in the past 6 months
- Treated with radioactive iodine in the past year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Randomized, Prospective Trial Comparing the Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy
In women who require thyroid hormone replacement medication, the investigators will compare 2 ways to adjust thyroid medication during pregnancy to determine superiority in maintaining optimal blood levels of thyroid hormone. Thyroid hormone requirements increase significantly in pregnancy and it is important that blood levels of thyroid hormone remain normal so the fetus, which cannot make its own thyroid hormone has enough for early prenatal development. This trial compares 2 methods for adjusting thyroid medicine during pregnancy in women with known thyroid disease. Pregnant women (age 18 to 45) who take thyroid medication will be randomized to either 1) a 2-dose per week increase in thyroid medicine once pregnancy is confirmed, followed by dose adjustments every 2-4 weeks, or 2) adjustments in thyroid medication every 2-4 weeks in micrograms per day based on results of blood tests. The investigators will compare thyroid hormone levels throughout pregnancy between the groups of mothers to determine which method is superior in meeting the increased thyroid hormone requirements during pregnancy.
- Conditions
- Pregnancy Related, Thyroid
- Being tested
- levothyroxine
- Keywords
- Thyroid Stimulating Hormone
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levothyroxineDrug
Also called Synthroid, Levoxyl
To compare two different methods of adjusting thyroid hormone replacement during pregnancy to maintain TSH within the normal reference range for pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Adjustment in number of doses of thyroid hormone per week | Experimental | Patients in this group will increase pre-pregnancy thyroid hormone dose by 2 doses/week (extra dose on Wednesday and Saturday). Further dose adjustment are made every 2-4 weeks based on serum TSH, as shown below:
* TSH>10mIU/L, increase by 3 doses/week
* TSH 5.0-9.9mIU/L, increase by 2 doses/week
* TSH 2.0-4.9mIU/L, increase by 1 dose/week
* TSH 0.4-1.9mIU/L, no change
* TSH<0.4mIU/L, decrease by 1 dose/week
* TSH<0.1mIU/L, decrease by 2 doses/week
* Thyroid hormone dose will NOT be decreased due to TSH<0.4mIU/L during the 1st trimester unless patient also has elevated circulating T4 and/or T3 levels, indicate of true hyperthyroidism. Receives: Drug: levothyroxine |
| Adjustment in micrograms per day of thyroid hormone | Experimental | Patients in this group adjust thyroid hormone dose based on Visit 1 TSH and pre-pregnancy thyroid hormone dose. Further dose adjustments are made every 2-4 weeks based on serum TSH, as shown below:
* TSH>10mIU/L, increase dose by 50mcg/day if dose <125mcg/day or increase by 75mcg/day if dose >125mcg
* TSH 5.0-9.9mIU/L, increase dose by 25mcg/day if dose <125mcg/day or increase by 50mcg/day if dose >125mcg
* TSH 2.0-4.9mIU/L, increase dose by 12.5mcg/day if dose <125mcg/day or increase by 25mcg/day if dose >125mcg
* TSH 0.4-1.9mIU/L, no change
* TSH<0.4mIU/L, decrease dose by 12.5mcg/day if dose <125mcg/day or decrease by 25mcg/day if dose >125mcg/day
* TSH<0.1mIU/L, decrease dose by 25mcg/day if dose <125mcg/day or decrease by 50mcg/day if dose >125mcg/day
* Thyroid hormone dose will NOT be decreased due to TSH<0.4mIU/L during the 1st trimester unless patient also has elevated circulating T4 and/or T3 levels, indicate of true hyperthyroidism. Receives: Drug: levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of TSH values within trimester-specific goal range per patient from study enrollment to delivery
% of TSH values within trimester-specific goal range according to study group
Measured: TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
Secondary outcomes (3)
Mean number of LT4 dose adjustment
Mean number of LT4 dose adjustments needed per patient in each group
Measured: Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
Mean number of LT4 dose adjustments by hypothyroidism etiology
Mean number of LT4 dose adjustments needed according to etiology of hypothyroidism in each group
Measured: Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
% of TSH values at goal according to anti-thyroid antibody status
TSH values within trimester specific goal range according to anti-thyroid antibody status
Measured: TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startAug 2011
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Sullivan, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115515
- Sponsor's protocol ID
- 2011-235
- Status last verified
- Mar 2018
- First submitted
- 7 Apr 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sullivan SD, Downs E, Popoveniuc G, Zeymo A, Jonklaas J, Burman KD. Randomized Trial Comparing Two Algorithms for Levothyroxine Dose Adjustment in Pregnant Women With Primary Hypothyroidism. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3499-3507. doi: 10.1210/jc.2017-01086.
PubMed 28911144
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Trial Comparing the Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy
- ClinicalTrials.gov ID
- NCT03115515
- Acronym / sponsor ID
- 2011-235
- Conditions
- Pregnancy Related, Thyroid
- Keywords
- Thyroid Stimulating Hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Apr 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.
In women who require thyroid hormone replacement medication, the investigators will compare 2 ways to adjust thyroid medication during pregnancy to determine superiority in maintaining optimal blood levels of thyroid hormone. Thyroid hormone requirements increase significantly in pregnancy and it is important that blood levels of thyroid hormone remain normal so the fetus, which cannot make its own thyroid hormone has enough for early prenatal development. This trial compares 2 methods for adjusting thyroid medicine during pregnancy in women with known thyroid disease. Pregnant women (age 18 to 45) who take thyroid medication will be randomized to either 1) a 2-dose per week increase in thyroid medicine once pregnancy is confirmed, followed by dose adjustments every 2-4 weeks, or 2) adjustments in thyroid medication every 2-4 weeks in micrograms per day based on results of blood tests. The investigators will compare thyroid hormone levels throughout pregnancy between the groups of mothers to determine which method is superior in meeting the increased thyroid hormone requirements during pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjustment in number of doses of thyroid hormone per week | Experimental | Drug: levothyroxinePatients in this group will increase pre-pregnancy thyroid hormone dose by 2 doses/week (extra dose on Wednesday and Saturday). Further dose adjustment are made every 2-4 weeks based on serum TSH, as shown below: * TSH>10mIU/L, increase by 3 doses/week * TSH 5.0-9.9mIU/L, increase by 2 doses/week * TSH 2.0-4.9mIU/L, increase by 1 dose/week * TSH 0.4-1.9mIU/L, no change * TSH<0.4mIU/L, decrease by 1 dose/week * TSH<0.1mIU/L, decrease by 2 doses/week * Thyroid hormone dose will NOT be decreased due to TSH<0.4mIU/L during the 1st trimester unless patient also has elevated circulating T4 and/or T3 levels, indicate of true hyperthyroidism. |
| Adjustment in micrograms per day of thyroid hormone | Experimental | Drug: levothyroxinePatients in this group adjust thyroid hormone dose based on Visit 1 TSH and pre-pregnancy thyroid hormone dose. Further dose adjustments are made every 2-4 weeks based on serum TSH, as shown below: * TSH>10mIU/L, increase dose by 50mcg/day if dose <125mcg/day or increase by 75mcg/day if dose >125mcg * TSH 5.0-9.9mIU/L, increase dose by 25mcg/day if dose <125mcg/day or increase by 50mcg/day if dose >125mcg * TSH 2.0-4.9mIU/L, increase dose by 12.5mcg/day if dose <125mcg/day or increase by 25mcg/day if dose >125mcg * TSH 0.4-1.9mIU/L, no change * TSH<0.4mIU/L, decrease dose by 12.5mcg/day if dose <125mcg/day or decrease by 25mcg/day if dose >125mcg/day * TSH<0.1mIU/L, decrease dose by 25mcg/day if dose <125mcg/day or decrease by 50mcg/day if dose >125mcg/day * Thyroid hormone dose will NOT be decreased due to TSH<0.4mIU/L during the 1st trimester unless patient also has elevated circulating T4 and/or T3 levels, indicate of true hyperthyroidism. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female between ages of 18-45 who takes thyroid hormone replacement medicine AND pregnant or plan to become pregnant in the near future.
Key exclusion criteria (8 listed)
- Males
- Younger than 18 or older than 45 years old
- More than 10 weeks pregnant at enrollment
- Iodine deficient
- Pregnant with more than one baby (i.e., twins, triplets, etc.)
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 |
|---|---|---|
| levothyroxineAlso: Synthroid, LevoxylTo compare two different methods of adjusting thyroid hormone replacement during pregnancy to maintain TSH within the normal reference range for pregnancy. | Drug | Adjustment in micrograms per day of thyroid hormone, Adjustment in number of doses of thyroid hormone per week |
Primary outcome
% of TSH values within trimester-specific goal range per patient from study enrollment to delivery
Time frame: TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
% of TSH values within trimester-specific goal range according to study group
3 secondary outcomes
Mean number of LT4 dose adjustment
Time frame: Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
Mean number of LT4 dose adjustments by hypothyroidism etiology
Time frame: Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
% of TSH values at goal according to anti-thyroid antibody status
Time frame: TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
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 29 Mar 2018.
- Derived from this study: PubMed 28911144Sullivan SD, Downs E, Popoveniuc G, Zeymo A, Jonklaas J, Burman KD. Randomized Trial Comparing Two Algorithms for Levothyroxine Dose Adjustment in Pregnant Women With Primary Hypothyroidism. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3499-3507. doi: 10.1210/jc.2017-01086.
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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 levothyroxine in people with Pregnancy Related and Thyroid, run by Medstar Health Research Institute at 1 site in United States.
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 1 inclusion and 8 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 29 Mar 2018. 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 United States. 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?
% of TSH values within trimester-specific goal range per patient from study enrollment to delivery (time frame: TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115515, which also lists 1 linked publication.
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 29 Mar 2018.