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Completed

NCT Number: NCT06135948

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Family Promotion Centre, Endocrinology Clinic

Sharjah city, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extra dose of L-thyroxine, 25 mcg during Ramadan

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Emirates Health Services (EHS)

Other Gov

Collaborators

  • University of Sharjah

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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