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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2022-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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L-thyroxine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

Hypothyroidism patients who received an increased dose of L-thyroxine, 25 mcg, n = 50

Group Type EXPERIMENTAL

Extra dose of L-thyroxine, 25 mcg during Ramadan

Intervention Type DRUG

Extra dose of L-thyroxine, 25 mcg during the month of Ramadan

Control Group

Hypothyroidism patients who received standard/regular dose of L-thyroxine, n = 46

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Extra dose of L-thyroxine, 25 mcg during Ramadan

Extra dose of L-thyroxine, 25 mcg during the month of Ramadan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients with any end organ damage
2. Pregnant or Breast-feeding women
3. Thyroid cancer
4. Patients not adhering to initial thyroxine medications.
5. Those receiving proton pump inhibitory therapy, dietary fiber, bile acid sequestrates, ferrous sulfate, sucralfate, calcium carbonate, aluminum-containing antacids, phosphate binders, and raloxifene.
6. Disease interferes with thyroxine absorption, coeliac disease, inflammatory bowel disease, lactose intolerance as well as Helicobacter pylori (H. pylori) infection and atrophic gastritis,
7. 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.
8. Patients were diagnosed with cardiovascular disorders, including angina, coronary artery disease, and hypertension.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR