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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Ente

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 Summary:

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.


Sponsor: Jocelyne Karam

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Maimonides Medical Center

Dates:
Date Received: September 14, 2015
Date Started: October 2015
Date Completion: October 2018
Last Updated: June 6, 2016
Last Verified: June 2016