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

L-thyroxine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06135948
• Other study ID #: EXL-THYROXINE2023
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: November 2023
• Source: Emirates Health Services (EHS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism
• L-thyroxine

Intervention

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

Locations

Country	Name	City	State
United Arab Emirates	Family Promotion Centre, Endocrinology Clinic	Sharjah

Sponsors (2)

Lead Sponsor	Collaborator
Emirates Health Services (EHS)	University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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