L-thyroxine Clinical Trial
Official title:
Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism: a Randomized Controlled Trial
Verified date | November 2023 |
Source | Emirates Health Services (EHS) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | Family Promotion Centre, Endocrinology Clinic | Sharjah |
Lead Sponsor | Collaborator |
---|---|
Emirates Health Services (EHS) | University of Sharjah |
United Arab Emirates,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00497575 -
Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism
|
N/A |