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

NCT06135948 | Completed Phase 4

• 1 other identifier: EXL-THYROXINE2023
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

L-thyroxine

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Hypothyroidism patients who received an increased dose of L-thyroxine, 25 mcg, n = 50

Drug: Extra dose of L-thyroxine, 25 mcg during Ramadan

Control Group

NO INTERVENTION

Hypothyroidism patients who received standard/regular dose of L-thyroxine, n = 46

Interventions

Extra dose of L-thyroxine, 25 mcg during Ramadan DRUG

Extra dose of L-thyroxine, 25 mcg during the month of Ramadan

Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emirates Health Services (EHS): lead
• University of Sharjah: collaborator

Study Sites (1)

Family Promotion Centre, Endocrinology Clinic

Sharjah city, United Arab Emirates

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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 Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: March 15, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

AE (1)