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

NCT02577367 | Withdrawn Phase 4

• 1 other identifier: 2015-05-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism

Keywords

Hypothyroidism; Tube Feeding

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Levothyroxine on empty stomach

EXPERIMENTAL

Levothyroxine will be given on empty stomach, by holding enteral feeding for 2 hours before and 2 hours after Levothyroxine administration

Drug: Levothyroxine

Levothyroxine during feeding

ACTIVE COMPARATOR

Levothyroxine will be given while the enteral feeding is running

Drug: Levothyroxine

Interventions

Levothyroxine DRUG

Administer Levothyroxine

Also known as: Synthroid

Levothyroxine during feeding; Levothyroxine on empty stomach

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jocelyne Karam: lead
• Maimonides Medical Center: collaborator

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jocelyne Karam, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Division of Endocrinology

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: October 16, 2015
• Study Start: October 1, 2015
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: September 22, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)