Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04878614
Collaborator
(none)
34
1
2
22.9
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Levothyroxine Tablet
  • Drug: Levothyroxine Sodium
Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This will be a randomized controlled trial.This will be a randomized controlled trial.
Masking:
Single (Participant)
Masking Description:
Participants will be randomized 1:1 to either continue current management with the same dose or to dose equivalent liquid levothyroxine
Primary Purpose:
Treatment
Official Title:
Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding
Actual Study Start Date :
May 5, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change of TSH [6 weeks]

      evaluate change in thyroid hormonal panel

    Secondary Outcome Measures

    1. percentage of patients with therapeutic FT4 [6 weeks]

      evaluate change in thyroid hormonal panel

    2. percentage of patients with therapeutic FT3 [6 weeks]

      evaluate change in thyroid hormonal panel

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Center for Human Nutrition Los Angeles California United States 90024

    Sponsors and Collaborators

    • University of California, Los Angeles

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vijaya Surampudi MD, Principal Investigator, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT04878614
    Other Study ID Numbers:
    • IRB#20-002097
    First Posted:
    May 7, 2021
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    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
    Keywords provided by Vijaya Surampudi MD, Principal Investigator, University of California, Los Angeles
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 7, 2021