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

Hypothyroidism Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02577367
• Other study ID #: 2015-05-02
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 1, 2015
• Est. completion date: April 8, 2020

Study information

• Verified date: August 2021
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 8, 2020
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Drug:
• Levothyroxine
Administer Levothyroxine

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
Jocelyne Karam	Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 weeks