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

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ClinicalTrials.gov Identifier: NCT02577367
Recruitment Status : Terminated (Hospital has a new protocol holding off feeding 2 hours for LT4 administration.)
First Posted : October 16, 2015
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
Maimonides Medical Center
Information provided by (Responsible Party):
Jocelyne Karam, Maimonides Medical Center

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.

Condition or disease Intervention/treatment Phase
Hypothyroidism Drug: Levothyroxine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2015
Actual Primary Completion Date : April 8, 2020
Actual Study Completion Date : April 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

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 Name: Synthroid

Active Comparator: Levothyroxine during feeding
Levothyroxine will be given while the enteral feeding is running
Drug: Levothyroxine
Administer Levothyroxine
Other Name: Synthroid




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02577367


Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Jocelyne Karam
Maimonides Medical Center
Investigators
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Principal Investigator: Jocelyne Karam, MD Maimonides Medical Center
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Responsible Party: Jocelyne Karam, Director, Division of Endocrinology, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02577367    
Other Study ID Numbers: 2015-05-02
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jocelyne Karam, Maimonides Medical Center:
Hypothyroidism
Tube Feeding
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases