Clinical trial NCT06135948: Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism
Official title: Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: L-thyroxine
Lead sponsor: Emirates Health Services (EHS)
Sponsor class: OTHER_GOV
Collaborators: name: University of Sharjah
First posted: 2023-11-18
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Effects of an extra dose of L-thyroxine during the month of Ramadan
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Family Promotion Centre, Endocrinology Clinic
Study officials:
References: