Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding

September 16, 2021 updated by: Jocelyne Karam

The Effect of Holding Tube Feeding When Administering Levothyroxine on the Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding

The study aims to describe the changes in Levothyroxine dosage requirements in patients with hypothyroidism started on enteral feeding, and assess whether giving levothyroxine on empty stomach affects the mean percentage increase expected in Levothyroxine dosage in these patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study will be a Randomized Controlled trial comparing the mean percentage of Levothyroxine dosage change in hypothyroid patients after the starting of enteral feeding in an inpatient setting in two different groups: a control group where Levothyroxine will be administered with continuous enteral nutrition, and an intervention group where enteral nutrition will be held for two hours before and two hours after the Levothyroxine administration.

The enrollment of eligible patients will be over two to three years and follow up will continue for the duration of the hospital stay or 12 weeks, which ever occurs earlier. Eligible patients will have thyroid function tests at enrollment (within three days of the starting of the tube feeding) and afterwards weekly. Levothyroxine dosage will be adjusted by the endocrinology research team according to the thyroid function results. Initial Levothyroxine dosage and subsequent dosages will be recorded and the mean percentage decrease or increase of Levothyroxine dosage required will be measured in each group. An eventual difference between the two groups mean percentage change will be tested for statistical significance.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults admitted to Maimonides Medical Center
  • Started on Enteral feeding within 3 days of enrollment: tube feeding, Percutaneous Endoscopic Gastrostomy or PEG tube feeding, or Jejunostomy tube feeding.
  • History of Hypothyroidism on a stable dose of Levothyroxine for at least four weeks prior to enteral feeding
  • TSH 0.2-10 mIU/ml at enrollment

Exclusion Criteria:

  • Concomitant administration of medications that affect thyroid function test including Cholestyramine, Sucralfate, Amiodarone, Lithium, Dopamine, Dobutamine and Dilantin at enrollment.
  • Pregnancy
  • Known untreated disease or surgery of the small intestine specifically the Jejenum.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levothyroxine on empty stomach
Levothyroxine will be given on empty stomach, by holding enteral feeding for 2 hours before and 2 hours after Levothyroxine administration
Drug: Levothyroxine
Administer Levothyroxine
Other Names:
  • Synthroid
Active Comparator: Levothyroxine during feeding
Levothyroxine will be given while the enteral feeding is running
Drug: Levothyroxine
Administer Levothyroxine
Other Names:
  • Synthroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean percentage change of Levothyroxine dosage
Time Frame: 12 weeks
The Primary outcome will be the measurement of the mean percentage change of levothyroxine dosage ( end of the enrollment dose as compared to baseline dose) in each of the two comparative groups: The control group of patients receiving Levothyroxine during the tube feeding, and the intervention group of patients receiving Levothyroxine on empty stomach (two hours before and two hours after holding the feeding)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jocelyne Karam

Collaborators

Maimonides Medical Center

Investigators

  • Principal Investigator: Jocelyne Karam, MD, Maimonides Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

April 8, 2020

Study Completion (Actual)

April 8, 2020

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-05-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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