Timing of Thyroxine Dose In Ramadan

NCT05421468 | Unknown

• 1 other identifier: ICT22J-001-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• Thyroid function

  Change in TSH level

  6 - 8 weeks

Study Arms (2)

Pre-Iftar (Breaking the fast)

ACTIVE COMPARATOR

To take thyroxine at breaking of fast with sip of water then wait 30-60 miuntes to eat iftar (breakfast).

Other: L-Thyroxine time B (5-15 minutes Before dawn)

Pre-Fajr (Starting the fast)

EXPERIMENTAL

To take thyroxine immediately before start of fast at predawn time regardless of last meal time.

Other: L-Thyroxine time B (5-15 minutes Before dawn)

Interventions

L-Thyroxine time B (5-15 minutes Before dawn) OTHER

Taking thyroxine at two different time points in relation to fasting and food intake; just before dawn and start of fast compared to the usual timing of 30-60minutes after the sunset breakfast meal.

Pre-Fajr (Starting the fast); Pre-Iftar (Breaking the fast)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (2)

Reem Alamoudi

Jeddah, 21423, Saudi Arabia

RECRUITING

KingAbullahIMRC

Jeddah, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 16, 2022
• Study Start: March 14, 2022
• Primary Completion: August 30, 2022
• Study Completion: October 30, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

SA (2)