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

Sponsor
Jocelyne Karam (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02577367
Collaborator
Maimonides Medical Center (Other)
0
Enrollment
1
Location
2
Arms
54.2
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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 Intervention/Treatment 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
Actual Enrollment :
0 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
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Apr 8, 2020
Actual Study Completion Date :
Apr 8, 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
Other Names:
  • Synthroid

    		•
    Active Comparator: Levothyroxine during feeding

    Levothyroxine will be given while the enteral feeding is running

    Drug: Levothyroxine
    Administer Levothyroxine
    Other Names:
  • Synthroid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean percentage change of Levothyroxine dosage [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

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Maimonides Medical Center Brooklyn New York United States 11219

    Sponsors and Collaborators

    • Jocelyne Karam
    • Maimonides Medical Center

    Investigators

    • Principal Investigator: Jocelyne Karam, MD, Maimonides Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jocelyne Karam, Director, Division of Endocrinology, Maimonides Medical Center
    ClinicalTrials.gov Identifier:
    NCT02577367
    Other Study ID Numbers:
    • 2015-05-02
    First Posted:
    Oct 16, 2015
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jocelyne Karam, Director, Division of Endocrinology, Maimonides Medical Center
    Hypothyroidism
    Tube Feeding
    Additional relevant MeSH terms:
    Hypothyroidism

    Study Results

    No Results Posted as of Sep 22, 2021