Back to resultsTiming of Thyroxine Dose In Ramadan
Primary Purpose
Hypothyroidism
Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
L-Thyroxine time B (5-15 minutes Before dawn)
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism
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
Sites / Locations
- Reem AlamoudiRecruiting
- KingAbullahIMRCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pre-Iftar (Breaking the fast)
Pre-Fajr (Starting the fast)
Arm Description
To take thyroxine at breaking of fast with sip of water then wait 30-60 miuntes to eat iftar (breakfast).
To take thyroxine immediately before start of fast at predawn time regardless of last meal time.
Outcomes
Primary Outcome Measures
Thyroid function
Change in TSH level
Secondary Outcome Measures
Full Information
NCT ID
NCT05421468
First Posted
May 27, 2022
Last Updated
June 12, 2022
Sponsor
King Abdullah International Medical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT05421468
Brief Title
Timing of Thyroxine Dose In Ramadan
Official Title
Timing of Thyroxine Dose In Ramadan; a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah International Medical Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-Iftar (Breaking the fast)
Arm Type
Active Comparator
Arm Description
To take thyroxine at breaking of fast with sip of water then wait 30-60 miuntes to eat iftar (breakfast).
Arm Title
Pre-Fajr (Starting the fast)
Arm Type
Experimental
Arm Description
To take thyroxine immediately before start of fast at predawn time regardless of last meal time.
Intervention Type
Other
Intervention Name(s)
L-Thyroxine time B (5-15 minutes Before dawn)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Thyroid function
Description
Change in TSH level
Time Frame
6 - 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Reem Alamoudi
City
Jeddah
ZIP/Postal Code
21423
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reem Alamoudi
Phone
0122266666
Email
amoudir@ngha.med.sa
First Name & Middle Initial & Last Name & Degree
Samah Nawar, MD
First Name & Middle Initial & Last Name & Degree
Hiba Alharbi, MD
First Name & Middle Initial & Last Name & Degree
Abdullah Alzahrani, MD
First Name & Middle Initial & Last Name & Degree
Ali Alqarni, MD
First Name & Middle Initial & Last Name & Degree
Yousef Saleh, MD
First Name & Middle Initial & Last Name & Degree
Anwar Borai
First Name & Middle Initial & Last Name & Degree
Majed Ramadan, PhD
Facility Name
KingAbullahIMRC
City
Jeddah
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reem M Alamoudi
Phone
966505641595
Email
amoudir@ngha.med.sa, refal2001@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Timing of Thyroxine Dose In Ramadan
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