Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding
Primary Purpose
Hypothyroidism
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levothyroxine Tablet
Levothyroxine Sodium
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism focused on measuring Levothyroxine, Enteral Nutrition, Gastrostomy Tube
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.
Sites / Locations
- UCLA Center for Human Nutrition
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Levothyroxine Management
Liquid Levothyroxine Management
Arm Description
Participants will continue with the same regimen
Participants will be treated with dose equivalent regimen through enteral feeding tube
Outcomes
Primary Outcome Measures
Change of TSH
evaluate change in thyroid hormonal panel
Secondary Outcome Measures
percentage of patients with therapeutic FT4
evaluate change in thyroid hormonal panel
percentage of patients with therapeutic FT3
evaluate change in thyroid hormonal panel
Full Information
NCT ID
NCT04878614
First Posted
May 4, 2021
Last Updated
April 6, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04878614
Brief Title
Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding
Official Title
Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated study low accrual numbers
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
Levothyroxine, Enteral Nutrition, Gastrostomy Tube
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized controlled trial.
Masking
Participant
Masking Description
Participants will be randomized 1:1 to either continue current management with the same dose or to dose equivalent liquid levothyroxine
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Levothyroxine Management
Arm Type
Active Comparator
Arm Description
Participants will continue with the same regimen
Arm Title
Liquid Levothyroxine Management
Arm Type
Experimental
Arm Description
Participants will be treated with dose equivalent regimen through enteral feeding tube
Intervention Type
Drug
Intervention Name(s)
Levothyroxine Tablet
Intervention Description
Standard clinical management
Intervention Type
Drug
Intervention Name(s)
Levothyroxine Sodium
Other Intervention Name(s)
Tirosint-SOL
Intervention Description
Liquid levothyroxine through enteral feeding tube
Primary Outcome Measure Information:
Title
Change of TSH
Description
evaluate change in thyroid hormonal panel
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
percentage of patients with therapeutic FT4
Description
evaluate change in thyroid hormonal panel
Time Frame
6 weeks
Title
percentage of patients with therapeutic FT3
Description
evaluate change in thyroid hormonal panel
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijiya Surampudi, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Human Nutrition
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
12. IPD Sharing Statement
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Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding
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