Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

NCT ID: NCT04878614

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2022-02-16

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Levothyroxine Management

Participants will continue with the same regimen

Group Type: ACTIVE_COMPARATOR

Levothyroxine Tablet

Intervention Type: DRUG

Standard clinical management

Liquid Levothyroxine Management

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

Group Type: EXPERIMENTAL

Levothyroxine Sodium

Intervention Type: DRUG

Liquid levothyroxine through enteral feeding tube

Interventions

Levothyroxine Tablet

Standard clinical management

Intervention Type: DRUG

Levothyroxine Sodium

Liquid levothyroxine through enteral feeding tube

Intervention Type: DRUG

Other Intervention Names

Tirosint-SOL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Vijaya Surampudi MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vijiya Surampudi, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Center for Human Nutrition

Los Angeles, California, United States

Countries

United States

Other Identifiers

IRB#20-002097

Identifier Type: -

Identifier Source: org_study_id