A Randomized trial comparing two different timing of taking thyroxine in patients with Hypothyroidism during fasting the month of Ramadan.

To date there is debate regarding the best timing of L-thyroxine administration during Ramadan as sufficient evidence is lacking. This study aims to compare two-time points of levothyroxine intake during Ramadan focusing on change in TSH, satisfaction and compliance.

A prospective, randomized, open label, multicenter Study. The first group will be will be instructed to take their L-thyroxin dose as per current guidlines at breaking of fast time (sunset) with sip of water then wait 30-60 minutes to consume Iftar meal. The second group (pre-Fajer prayer), patients are going to be instructed to take L-thyroxin dose immediately before start of fast, i.e. Alfajer (dawn) regardless of Suhoor time. The values of Thyroid stimulating hormone (TSH) will be measured two weeks before Ramadan, and 2-4 weeks after Ramadan for comparison.

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