Timing of Thyroxine Dose In Ramadan

Not Applicable

• Conditions: Hypothyroidism
• Interventions: Other: L-Thyroxine time B (5-15 minutes Before dawn)

• Registration Number: NCT05421468
• Lead Sponsor: King Abdullah International Medical Research Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-14
• Study First Submitted: 2022-05-27
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-12
• Last Update Submitted: 2022-06-12
• Study First Posted: 2022-06-16
• Last Update Posted: 2022-06-16
• Primary Completion: 2022-08-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-Iftar (Breaking the fast)	L-Thyroxine time B (5-15 minutes Before dawn)	To take thyroxine at breaking of fast with sip of water then wait 30-60 miuntes to eat iftar (breakfast).
Pre-Fajr (Starting the fast)	L-Thyroxine time B (5-15 minutes Before dawn)	To take thyroxine immediately before start of fast at predawn time regardless of last meal time.

Primary Outcome Measures

Name	Time	Method
Thyroid function	6 - 8 weeks	Change in TSH level

Trial Locations

Locations (2)

Reem Alamoudi; 🇸🇦 Jeddah, Saudi Arabia

KingAbullahIMRC; 🇸🇦 Jeddah, Saudi Arabia