Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

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.

Study Overview

• Status: Terminated
• Conditions: Hypothyroidism
• Intervention / Treatment: Drug: Levothyroxine Tablet; Drug: Levothyroxine Sodium

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vijiya D Surampudi, MD; Phone Number: 310-206-1987; Email: vsurampudi@mednet.ucla.edu
• Study Contact Backup: Name: Jeraldine Guzman, BS; Phone Number: 310-206-8292; Email: jbguzman@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA Center for Human Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Levothyroxine Management; Participants will continue with the same regimen	Drug: Levothyroxine Tablet; Standard clinical management
Experimental: Liquid Levothyroxine Management; Participants will be treated with dose equivalent regimen through enteral feeding tube	Drug: Levothyroxine Sodium; Liquid levothyroxine through enteral feeding tube; Other Names: Tirosint-SOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of TSH	evaluate change in thyroid hormonal panel	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients with therapeutic FT4	evaluate change in thyroid hormonal panel	6 weeks
percentage of patients with therapeutic FT3	evaluate change in thyroid hormonal panel	6 weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Vijiya Surampudi, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): February 16, 2022
• Study Completion (Actual): February 16, 2022

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Enteral Nutrition; Levothyroxine; Gastrostomy Tube
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: IRB#20-002097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes