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

Sponsor

Emirates Health Services (EHS) (Other)

Overall Status

Completed

CT.gov ID

NCT06135948

Collaborator

University of Sharjah (Other)

103

Enrollment

Location

Arms

Actual Duration (Months)

34.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
L-thyroxine	Drug: Extra dose of L-thyroxine, 25 mcg during Ramadan	Phase 4

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model 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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 15, 2022

Actual Primary Completion Date :

Jun 15, 2022

Actual Study Completion Date :

Jun 15, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Effects of an extra dose of L-thyroxine during the month of Ramadan [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

The inclusion criteria for participants will include:

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

Exclusion Criteria:

Patients with any end organ damage
Pregnant or Breast-feeding women
Thyroid cancer
Patients not adhering to initial thyroxine medications.
Those receiving proton pump inhibitory therapy, dietary fiber, bile acid sequestrates, ferrous sulfate, sucralfate, calcium carbonate, aluminum-containing antacids, phosphate binders, and raloxifene.
Disease interferes with thyroxine absorption, coeliac disease, inflammatory bowel disease, lactose intolerance as well as Helicobacter pylori (H. pylori) infection and atrophic gastritis,
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.
Patients were diagnosed with cardiovascular disorders, including angina, coronary artery disease, and hypertension.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Family Promotion Centre, Endocrinology Clinic	Sharjah		United Arab Emirates

Sponsors and Collaborators

Emirates Health Services (EHS)
University of Sharjah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Nawal Almutawa,MD,FCCE,FACE,EMPA, Principle investigator,Dr. Nawal Al mutawa, Consultant I.M, Endocrinologist & Dialectologist, Head of Department of Endocrinology & Dialectology, Emirates Health Service, UAE MD, I.M board BIM (FCCE (FACE), (EMPA) Past Medical Director, Emirates Health Services (EHS)

ClinicalTrials.gov Identifier:

NCT06135948

Other Study ID Numbers:

EXL-THYROXINE2023

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypothyroidism

Study Results

No Results Posted as of Nov 18, 2023