HypothyroidismPhase 4NCT04878614
Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding
A Phase 4 study testing Levothyroxine Tablet and Levothyroxine Sodium in people with Hypothyroidism, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to test a liquid levothyroxine formula and examine if it will lead to improvement in management of thyroid function and if it improves hypothyroid symptoms that patients experience. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Levothyroxine Tablet and Levothyroxine Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 16 Feb 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 years old or older
- G-tube/G-J tube dependent for medication administration
- Hypothyroid patients on levothyroxine tablet
- TSH>5 on levothyroxine
Who cannot join
- J-tube
- Unstable cardiac condition
- Unstable gastrointestinal condition
- Unable to reliably administer medication
- Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- In the opinion of the study investigator, any subject who demonstrate a risk of non-compliance with study procedure, or one who cannot read, understand or complete study - related materials.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition
Los Angeles, California, 90024
About this study
The purpose of this study is to test a liquid levothyroxine formula and examine if it will lead to improvement in management of thyroid function and if it improves hypothyroid symptoms that patients experience.
Read the detailed description
Patients who require enteral nutrition through an enteral feeding tube and have hypothyroidism often struggle with the management of hypothyroidism. Hypothyroidism usually requires lifelong treatment except in some cases. It has been clinically observed the traditional management of hypothyroidism is to crush the tablet and administer the medical through the enteral nutrition tube and hold the feeds for one hour. However, management of the hormonal profile has been noted to have variable results with this method. Limited data is available about the effectiveness of levothyroxine liquid formulation in outpatients' dependent on enteral feeding tubes for administration.
Therefore, we propose a study to assess if daily treatment of, Tirosint-SOL (liquid levothyroxine, IBSA pharma Inc.), will improve thyroid function tests in individuals requiring enteral nutrition and are hypothyroid in a prospective, randomized study in a population requiring enteral nutrition. We hypothesize that Tirosint-SOL will lead to improvement in management in their thyroid function tests resulting in possible improvement in hypothyroid symptoms experienced by the patients.
This will be a randomized controlled trial. The study will be conducted in patients who have uncontrolled hypothyroidism on levothyroxine therapy. These patients will also be dependent on enteral nutrition and medication administration through the gastrostomy tube. The participants will be followed at UCLA Enteral Nutrition Clinic. Participants will be randomized 1:1 to either continue current management with the same dose or to dose equivalent liquid levothyroxine. At baseline (week 0) and week 6-8, TSH and thyroid function tests will be performed. In addition, medical history and physical, body weight, HR, blood pressure, nutritional intake by a registered dietitian will be done at each visit.
- Conditions
- Hypothyroidism
- Being tested
- Levothyroxine Tablet, Levothyroxine Sodium
- Keywords
- Levothyroxine, Enteral Nutrition, Gastrostomy Tube
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine TabletDrug
Standard clinical management
Levothyroxine SodiumDrug
Also called Tirosint-SOL
Liquid levothyroxine through enteral feeding tube
| Study group | Role | What they receive |
|---|---|---|
| Standard Levothyroxine Management | Active comparator | Participants will continue with the same regimen Receives: Drug: Levothyroxine Tablet |
| Liquid Levothyroxine Management | Experimental | Participants will be treated with dose equivalent regimen through enteral feeding tube Receives: Drug: Levothyroxine Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of TSH
evaluate change in thyroid hormonal panel
Measured: 6 weeks
Secondary outcomes (2)
percentage of patients with therapeutic FT4
evaluate change in thyroid hormonal panel
Measured: 6 weeks
percentage of patients with therapeutic FT3
evaluate change in thyroid hormonal panel
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start5 May 2021
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Why it stopped: Sponsor terminated study low accrual numbers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Model description
- This will be a randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijaya Surampudi MD, University of California, Los Angeles
- Investigators
- Vijiya Surampudi, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878614
- Sponsor's protocol ID
- IRB#20-002097
- Status last verified
- Apr 2023
- First submitted
- 4 May 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding
- ClinicalTrials.gov ID
- NCT04878614
- Acronym / sponsor ID
- IRB#20-002097
- Conditions
- Hypothyroidism
- Keywords
- Levothyroxine, Enteral Nutrition, Gastrostomy Tube
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated study low accrual numbers
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 7 May 2021 (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 purpose of this study is to test a liquid levothyroxine formula and examine if it will lead to improvement in management of thyroid function and if it improves hypothyroid symptoms that patients experience.
Detailed description
Patients who require enteral nutrition through an enteral feeding tube and have hypothyroidism often struggle with the management of hypothyroidism. Hypothyroidism usually requires lifelong treatment except in some cases. It has been clinically observed the traditional management of hypothyroidism is to crush the tablet and administer the medical through the enteral nutrition tube and hold the feeds for one hour. However, management of the hormonal profile has been noted to have variable results with this method. Limited data is available about the effectiveness of levothyroxine liquid formulation in outpatients' dependent on enteral feeding tubes for administration.
Therefore, we propose a study to assess if daily treatment of, Tirosint-SOL (liquid levothyroxine, IBSA pharma Inc.), will improve thyroid function tests in individuals requiring enteral nutrition and are hypothyroid in a prospective, randomized study in a population requiring enteral nutrition. We hypothesize that Tirosint-SOL will lead to improvement in management in their thyroid function tests resulting in possible improvement in hypothyroid symptoms experienced by the patients.
This will be a randomized controlled trial. The study will be conducted in patients who have uncontrolled hypothyroidism on levothyroxine therapy. These patients will also be dependent on enteral nutrition and medication administration through the gastrostomy tube. The participants will be followed at UCLA Enteral Nutrition Clinic. Participants will be randomized 1:1 to either continue current management with the same dose or to dose equivalent liquid levothyroxine. At baseline (week 0) and week 6-8, TSH and thyroid function tests will be performed. In addition, medical history and physical, body weight, HR, blood pressure, nutritional intake by a registered dietitian will be done at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Standard Levothyroxine Management | Active comparator | Drug: Levothyroxine TabletParticipants will continue with the same regimen |
| Liquid Levothyroxine Management | Experimental | Drug: Levothyroxine SodiumParticipants will be treated with dose equivalent regimen through enteral feeding tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 years old or older
- G-tube/G-J tube dependent for medication administration
- Hypothyroid patients on levothyroxine tablet
- TSH>5 on levothyroxine
Key exclusion criteria (6 listed)
- J-tube
- Unstable cardiac condition
- Unstable gastrointestinal condition
- Unable to reliably administer medication
- Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
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 TabletStandard clinical management | Drug | Standard Levothyroxine Management |
| Levothyroxine SodiumAlso: Tirosint-SOLLiquid levothyroxine through enteral feeding tube | Drug | Liquid Levothyroxine Management |
Primary outcome
Change of TSH
Time frame: 6 weeks
evaluate change in thyroid hormonal panel
2 secondary outcomes
percentage of patients with therapeutic FT4
Time frame: 6 weeks
percentage of patients with therapeutic FT3
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Sponsor terminated study low accrual numbers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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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.
Vijiya Surampudi, MD principal investigator
University of California, Los Angeles
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 Tablet and Levothyroxine Sodium in people with Hypothyroidism, run by University of California, Los Angeles 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Apr 2023. 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.
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?
The study was stopped early (reason given: Sponsor terminated study low accrual numbers). Results are not available in the source record.
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?
Change of TSH (time frame: 6 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 10 Apr 2023.