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Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

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ClinicalTrials.gov Identifier: NCT04878614
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Vijaya Surampudi MD, University of California, Los Angeles

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
Hypothyroidism 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

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 Name: Tirosint-SOL




Primary Outcome Measures :
  1. Change of TSH [ Time Frame: 6 weeks ]
    evaluate change in thyroid hormonal panel


Secondary Outcome Measures :
  1. percentage of patients with therapeutic FT4 [ Time Frame: 6 weeks ]
    evaluate change in thyroid hormonal panel

  2. percentage of patients with therapeutic FT3 [ Time Frame: 6 weeks ]
    evaluate change in thyroid hormonal panel



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878614


Contacts
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Contact: Vijiya D Surampudi, MD 310-206-1987 vsurampudi@mednet.ucla.edu
Contact: Jeraldine Guzman, BS 310-206-8292 jbguzman@mednet.ucla.edu

Locations
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United States, California
UCLA Center for Human Nutrition Recruiting
Los Angeles, California, United States, 90024
Contact: Vijiya Surampudi, MD    310-206-1987    vsurampudi@mednet.ucla.edu   
Contact: Jeraldine B Guzman, BS    310-206-8292    jbguzman@mednet.ucla.edu   
Principal Investigator: Vijiya Surampudi, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Vijiya Surampudi, MD University of California, Los Angeles
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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    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021

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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, University of California, Los Angeles:
Levothyroxine
Enteral Nutrition
Gastrostomy Tube
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases