Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism

November 16, 2023 updated by: Dr. Nawal Almutawa,MD,FCCE,FACE,EMPA, Emirates Health Services (EHS)

Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism: a Randomized Controlled Trial

The study aims to compare the mean change in Thyroid Stimulating Hormone (TSH) levels among patients with hypothyroidism treated with an increased dose of L-thyroxine (treatment group) versus standard/regular dose of L-thyroxine (control group) during the month of Ramadan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study is an open-label, two-arm parallel groups, randomized controlled clinical trial that included Emirati patients with hypothyroidism who attended the Family Promotion Centre, Endocrinology Clinic, regularly. Eligible participants (n = 103) were randomly allocated to the treatment group (patients who received an increased dose of L-thyroxine, 25 mcg, n = 50) and the control group (patients who received standard/regular dose of L-thyroxine, n = 46). Both groups attended 5 visits before, during, and after Ramadan. Several tests were conducted including thyroid function, lipid profile, HbA1c, and Vitamin D.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

The inclusion criteria for participants will include:

  1. Male and female patients with primary hypothyroidism.
  2. Patients with stable TSH
  3. Aged between 18 and 70 years.
  4. Patients regularly fasting for at least 25- 30 days during Ramadan.
  5. Emirati nationals (100% health care coverage)

Exclusion Criteria:

  1. Patients with any end organ damage
  2. Pregnant or Breast-feeding women
  3. Thyroid cancer
  4. Patients not adhering to initial thyroxine medications.
  5. Those receiving proton pump inhibitory therapy, dietary fiber, bile acid sequestrates, ferrous sulfate, sucralfate, calcium carbonate, aluminum-containing antacids, phosphate binders, and raloxifene.
  6. Disease interferes with thyroxine absorption, coeliac disease, inflammatory bowel disease, lactose intolerance as well as Helicobacter pylori (H. pylori) infection and atrophic gastritis,
  7. Several other factors cause treatment failures such as fiber-rich food, soy protein, grapefruit, and aluminum antacids, which interfere with Thyroxine absorption. In addition to calcium carbonate and ferrous sulfate.
  8. Patients were diagnosed with cardiovascular disorders, including angina, coronary artery disease, and hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Hypothyroidism patients who received an increased dose of L-thyroxine, 25 mcg, n = 50
Drug: Extra dose of L-thyroxine, 25 mcg during Ramadan
Extra dose of L-thyroxine, 25 mcg during the month of Ramadan
No Intervention: Control Group
Hypothyroidism patients who received standard/regular dose of L-thyroxine, n = 46

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of an extra dose of L-thyroxine during the month of Ramadan
Time Frame: 3 months
to compare the mean change in Thyroid Stimulating Hormone (TSH) levels among patients with hypothyroidism treated with an increased dose of L-thyroxine (treatment group) versus standard/regular dose of L-thyroxine (control group) during the month of Ramadan.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emirates Health Services (EHS)

Collaborators

University of Sharjah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

November 12, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXL-THYROXINE2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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