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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

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

Clinicaltrials.gov identifier NCT02577367

Recruitment Status Recruiting

First Posted October 16, 2015

Last update posted October 2, 2018

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.

  • Condition or Disease:Hypothyroidism
  • Intervention/Treatment: Drug: Levothyroxine
  • Phase: 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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 24 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
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: October 2020
Arms and interventions
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
Active Comparator: Levothyroxine during feeding
Levothyroxine will be given while the enteral feeding is running
Drug: Levothyroxine
Administer Levothyroxine
Outcome Measures
  • 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)
Eligibility Criteria
  • Ages Eligible for Study: 18 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.

Contacts and Locations
Contacts

Contact: Jocelyne Karam, MD 718-283-5906 jkaram@maimonidesmed.org

Locations

United States, New York
Maimonides Medical Center
Brooklyn

Sponsors and Collaborators

Jocelyne Karam

Maimonides Medical Center

Investigators

Principal Investigator: Jocelyne Karam, MD Maimonides Medical Center

More Information
  • Responsible Party: Jocelyne Karam
  • ClinicalTrials.gov Identifier: NCT02577367 History of Changes
  • Other Study ID Numbers: 2015-05-02
  • First Posted: October 16, 2015 Key Record Dates
  • Last Update Posted: October 2, 2018
  • Last Verified: October 2018
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Keywords provided by Jocelyne Karam: Hypothyroidism Tube Feeding
  • Additional relevant MeSH terms: Hypothyroidism