Timing of Thyroxine Dose In Ramadan

NCT ID: NCT05421468

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2022-10-30

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.

Conditions

Hypothyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-Iftar (Breaking the fast)

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdullah International Medical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Reem Alamoudi

Jeddah, , Saudi Arabia

Site Status: RECRUITING

KingAbullahIMRC

Jeddah, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Facility Contacts

Reem Alamoudi

Role: primary

amoudir@ngha.med.sa

0122266666

Reem M Alamoudi

Role: primary

amoudir@ngha.med.sa, refal2001@yahoo.com

966505641595

Other Identifiers

ICT22J-001-01

Identifier Type: -

Identifier Source: org_study_id