Impact of Increasing Levothyroxine Dose in Ramadan for UA... | NCT06135948

Studies
Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism

NCT06135948

Sponsor

Emirates Health Services (EHS)

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

103Actual

Phase

Phase 4

Conditions

L-thyroxine

Interventions

Extra dose of L-thyroxine, 25 mcg during Ramadan

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2022Actual

Primary Completion Date

Jun 15, 2022Actual

Completion Date

Jun 15, 2022Actual

First Submitted Date

Nov 12, 2023

First Submission Date that Met QC Criteria

Nov 12, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2023

Last Update Posted Date

Nov 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Nawal Almutawa,MD,FCCE,FACE,EMPA, Principle investigator,Dr. Nawal Al mutawa, Consultant I.M, Endocrinologist & Dialectologist, Head of Department of Endocrinology & Dialectology, Emirates Health Service, UAE MD, I.M board BIM (FCCE (FACE), (EMPA) Past Medical Director, Emirates Health Services (EHS)Principal Investigator

Lead Sponsor

Emirates Health Services (EHS)OTHER_GOV

Collaborators

Name	Class
University of Sharjah	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to compare the mean change in Thyroid Stimulating Hormone (TSH) levels among patients with hypothyroidism treated with an increased dose of L-thyroxine (treatment group) versus standard/regular dose of L-thyroxine (control group) during the month of Ramadan.

Detailed Description

The present study is an open-label, two-arm parallel groups, randomized controlled clinical trial that included Emirati patients with hypothyroidism who attended the Family Promotion Centre, Endocrinology Clinic, regularly. Eligible participants (n = 103) were randomly allocated to the treatment group (patients who received an increased dose of L-thyroxine, 25 mcg, n = 50) and the control group (patients who received standard/regular dose of L-thyroxine, n = 46). Both groups attended 5 visits before, during, and after Ramadan. Several tests were conducted including thyroid function, lipid profile, HbA1c, and Vitamin D.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental	Hypothyroidism patients who received an increased dose of L-thyroxine, 25 mcg, n = 50	Drug: Extra dose of L-thyroxine, 25 mcg during Ramadan
Control Group	No Intervention	Hypothyroidism patients who received standard/regular dose of L-thyroxine, n = 46

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extra dose of L-thyroxine, 25 mcg during Ramadan	Drug	Extra dose of L-thyroxine, 25 mcg during the month of Ramadan	Intervention Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of an extra dose of L-thyroxine during the month of Ramadan	to compare the mean change in Thyroid Stimulating Hormone (TSH) levels among patients with hypothyroidism treated with an increased dose of L-thyroxine (treatment group) versus standard/regular dose of L-thyroxine (control group) during the month of Ramadan.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

The inclusion criteria for participants will include:

Male and female patients with primary hypothyroidism.
Patients with stable TSH
Aged between 18 and 70 years.
Patients regularly fasting for at least 25- 30 days during Ramadan.
Emirati nationals (100% health care coverage)

Exclusion Criteria:

Patients with any end organ damage
Pregnant or Breast-feeding women
Thyroid cancer
Patients not adhering to initial thyroxine medications.
Those receiving proton pump inhibitory therapy, dietary fiber, bile acid sequestrates, ferrous sulfate, sucralfate, calcium carbonate, aluminum-containing antacids, phosphate binders, and raloxifene.
Disease interferes with thyroxine absorption, coeliac disease, inflammatory bowel disease, lactose intolerance as well as Helicobacter pylori (H. pylori) infection and atrophic gastritis,
Several other factors cause treatment failures such as fiber-rich food, soy protein, grapefruit, and aluminum antacids, which interfere with Thyroxine absorption. In addition to calcium carbonate and ferrous sulfate.
Patients were diagnosed with cardiovascular disorders, including angina, coronary artery disease, and hypertension.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Model Description