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Thyroid Hormone Replacement

Levothyroxine on empty stomach for Hypothyroidism

Phase 4
Waitlist Available
Led By Jocelyne Karam, MD
Research Sponsored by Jocelyne Karam
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean percentage change of Levothyroxine dosage

Side effects data

From 2022 Phase 4 trial • 52 Patients • NCT04288115
5%
Gangrene of toe
5%
catheter ablation of arrhythmogenic focus
5%
revision posterior decompression cervical cord and fusion
5%
transurethral prostatectomy
5%
diarrhea
5%
angina pectoris
5%
fall
5%
fluoroscopy guided percutaneous insertion of drug eluting stent into coronary artery with contrast
5%
hypertensive disorder
5%
low blood pressure
5%
bronchitis
5%
intravitreal injection of anti-vascular endothelial growth factor
5%
carcinoma of prostate
5%
paresthesia of upper limb
5%
restenosis
5%
scalp itchy
5%
shoulder pain
5%
simple extraction of tooth
5%
spasm
5%
polyp of transverse colon
5%
polyp of sigmoid colon
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group ("Real Discontinuation")
Levothyroxine Group ("Sham Discontinuation")

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Levothyroxine on empty stomachExperimental Treatment1 Intervention
Levothyroxine will be given on empty stomach, by holding enteral feeding for 2 hours before and 2 hours after Levothyroxine administration
Group II: Levothyroxine during feedingActive Control1 Intervention
Levothyroxine will be given while the enteral feeding is running
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levothyroxine
FDA approved

Find a Location

Who is running the clinical trial?

Jocelyne KaramLead Sponsor
Maimonides Medical CenterOTHER
70 Previous Clinical Trials
15,434 Total Patients Enrolled
Jocelyne Karam, MDPrincipal InvestigatorMaimonides Medical Center
~0 spots leftby Oct 2025
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