Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding
Primary Purpose
Hypothyroidism
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levothyroxine
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism focused on measuring Hypothyroidism, Tube Feeding
Eligibility Criteria
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.
Sites / Locations
- Maimonides Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Levothyroxine on empty stomach
Levothyroxine during feeding
Arm Description
Levothyroxine will be given on empty stomach, by holding enteral feeding for 2 hours before and 2 hours after Levothyroxine administration
Levothyroxine will be given while the enteral feeding is running
Outcomes
Primary Outcome Measures
Mean percentage change of Levothyroxine dosage
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02577367
First Posted
September 14, 2015
Last Updated
September 16, 2021
Sponsor
Jocelyne Karam
Collaborators
Maimonides Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02577367
Brief Title
Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lost interest in current study
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jocelyne Karam
Collaborators
Maimonides Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
Hypothyroidism, Tube Feeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levothyroxine on empty stomach
Arm Type
Experimental
Arm Description
Levothyroxine will be given on empty stomach, by holding enteral feeding for 2 hours before and 2 hours after Levothyroxine administration
Arm Title
Levothyroxine during feeding
Arm Type
Active Comparator
Arm Description
Levothyroxine will be given while the enteral feeding is running
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
Synthroid
Intervention Description
Administer Levothyroxine
Primary Outcome Measure Information:
Title
Mean percentage change of Levothyroxine dosage
Description
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)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyne Karam, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding
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