L-thyroxine
Conditions
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.
Detailed 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.
Interventions
DRUGExtra dose of L-thyroxine, 25 mcg during Ramadan
Extra dose of L-thyroxine, 25 mcg during the month of Ramadan
Sponsors
University of Sharjah
Emirates Health Services (EHS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Arab Emirates
Outcome results
None listed