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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT02577367
Recruitment Status Recruiting
First Posted October 16, 2015
Last update posted October 2, 2018
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.
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.
|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
|Active Comparator: Levothyroxine during feeding
Levothyroxine will be given while the enteral feeding is running
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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
- Concomitant administration of medications that affect thyroid function test including
Cholestyramine, Sucralfate, Amiodarone, Lithium, Dopamine, Dobutamine and Dilantin at
- Known untreated disease or surgery of the small intestine specifically the Jejenum.
Contact: Jocelyne Karam, MD 718-283-5906 firstname.lastname@example.org
United States, New York
Maimonides Medical Center
Maimonides Medical Center
Principal Investigator: Jocelyne Karam, MD Maimonides Medical Center