Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

NCT04878614 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: IRB#20-002097
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism

Keywords

Levothyroxine; Enteral Nutrition; Gastrostomy Tube

Outcome Measures

Primary Outcomes (1)

• Change of TSH

  evaluate change in thyroid hormonal panel

  6 weeks

Secondary Outcomes (2)

• percentage of patients with therapeutic FT4

  6 weeks

• percentage of patients with therapeutic FT3

  6 weeks

Study Arms (2)

Standard Levothyroxine Management

ACTIVE COMPARATOR

Participants will continue with the same regimen

Drug: Levothyroxine Tablet

Liquid Levothyroxine Management

EXPERIMENTAL

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

Drug: Levothyroxine Sodium

Interventions

Levothyroxine Tablet DRUG

Standard clinical management

Standard Levothyroxine Management

Levothyroxine Sodium DRUG

Liquid levothyroxine through enteral feeding tube

Also known as: Tirosint-SOL

Liquid Levothyroxine Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Vijiya Surampudi, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomized 1:1 to either continue current management with the same dose or to dose equivalent liquid levothyroxine
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a randomized controlled trial.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: May 5, 2021
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

US (1)