Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

Recruiting in Palo Alto (17 mi)

Overseen by Vijiya Surampudi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a liquid form of levothyroxine to see if it better manages thyroid function in patients with hypothyroidism who use feeding tubes. These patients often struggle with traditional tablet forms of the medication. The liquid form is expected to be absorbed more consistently, potentially improving their thyroid levels and symptoms. Levothyroxine is a standard therapy for hypothyroidism, and liquid formulations have been shown to provide better absorption and thyroid hormone control compared to tablet forms.

Research Team

Vijiya Surampudi, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

TSH>5 on levothyroxine

Adults age 18 years old or older

G-tube/G-J tube dependent for medication administration

Exclusion Criteria

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.

You have an unstable stomach or bowel condition.

Treatment Details

Interventions

• Levothyroxine Sodium (Thyroid Hormone Replacement)
• Levothyroxine Tablet (Thyroid Hormone Replacement)

Participant Groups

Group I: Liquid Levothyroxine Management Experimental Treatment 1 Intervention

Participants will be treated with dose equivalent regimen through enteral feeding tube

Group II: Standard Levothyroxine Management Active Control 1 Intervention

Participants will continue with the same regimen

Levothyroxine Sodium is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Levothyroxine Sodium for:

• Hypothyroidism
• Thyroid nodules
• Thyroid cancer

Approved in Japan as Levothyroxine Sodium for:

• Hypothyroidism
• Thyroid nodules
• Thyroid cancer

Approved in China as Levothyroxine Sodium for:

• Hypothyroidism
• Thyroid nodules
• Thyroid cancer

Approved in Switzerland as Levothyroxine Sodium for:

• Hypothyroidism
• Thyroid nodules
• Thyroid cancer

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA