Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

Conditions
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Hypothyroidism

Intervention / Treatment
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* Drug: Levothyroxine Tablet
* Drug: Levothyroxine Sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a randomized controlled trial.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levothyroxine, Enteral Nutrition, Gastrostomy Tube