Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT05421468
Eligibility Criteria:
Inclusion Criteria:
* Saudi patient (males and female) above 18 years with Primary hypothyroidism on levothyroxine replacement who are willing to fast during Ramadan.
* Patients with controlled thyroid function for last 3 months on same dose of levothyroxine.
Exclusion Criteria:
* Pregnant or lactating women.
* Uncontrolled thyroid function test three months prior Ramadan.
* Thyroid cancer patients who require suppressed TSH.
* Central Hypothyroidism, patient with acute illness.
* Patients diagnosed with malabsorption i.e., Celiac Disease, Short bowel, Bariatric surgeries
* Use of certain Medications like systemic glucocorticoids, activated charcoal, sucralfate, aluminum hydroxide antacid, bile acid sequestrants, iron, calcium carbonate, PPI, rifampicin, and antiepileptic medications
* Renal or hepatic disease:
* Creatinine clearance \<0.6 ml/s or serum creatinine ≥200 μmol/l
* Alanine transferase ≥2.5 times the upper limit of normal
* Active liver disease including jaundice, chronic hepatitis, previous liver transplant
* Unwillingness to be randomized or to sign informed consent
* Known Psychiatric Disorders
* Known uncontrolled substance abuse or alcoholism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05421468
Study Brief:
Protocol Section:
NCT05421468