Hypothyroidism
Conditions
Keywords
Levothyroxine, Enteral Nutrition, Gastrostomy Tube
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.
Interventions
DRUGLevothyroxine Tablet
Standard clinical management
Liquid levothyroxine through enteral feeding tube
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be randomized 1:1 to either continue current management with the same dose or to dose equivalent liquid levothyroxine
Intervention model description
This will be a randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of TSH | 6 weeks | evaluate change in thyroid hormonal panel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients with therapeutic FT4 | 6 weeks | evaluate change in thyroid hormonal panel |
| percentage of patients with therapeutic FT3 | 6 weeks | evaluate change in thyroid hormonal panel |
Countries
United States
Outcome results
None listed