Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism

NCT ID: NCT06276205

Last Updated: 2025-03-11

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

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-01-01

Brief Summary

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The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.

The main question it aims to answer is:

• whether adding Vitamin D to standard therapy has any additional benefits

Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.

Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them

Detailed Description

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Conditions

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Hypothyroidism Primary Lipid Disorder Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D + Levothyroxine

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

if Vitamin D level suboptimal, 50,000 IU/week for 8 weeks followed by 2000 IU/d

if optimal Vitamin D level, 2000 IU/d

Levothyroxin

Intervention Type DRUG

commenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response

Levothyroxine Alone

Group Type ACTIVE_COMPARATOR

Levothyroxin

Intervention Type DRUG

commenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response

Interventions

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Vitamin D

if Vitamin D level suboptimal, 50,000 IU/week for 8 weeks followed by 2000 IU/d

if optimal Vitamin D level, 2000 IU/d

Intervention Type DRUG

Levothyroxin

commenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response

Intervention Type DRUG

Other Intervention Names

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Thyroxine

Eligibility Criteria

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Inclusion Criteria

* Patients of all genders.
* Age more than 12 years
* Biochemically hypothyroid (overt \& subclinical)
* Vitamin D level between 10-70ng/ml
* TC \<250mg/dl, LDL 70-144mg/dl, TGs 150-499mg/dl

Exclusion Criteria

* Known Atherosclerotic Cardiovascular Disease
* BMI\>35kg/m2
* History of Alcoholism (\>14 units/day)
* History of Beta blocker intake
* Patient taking lipid lowering drugs
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

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Sidrah Lodhi

Assistant Professor of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Edward Medical University

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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1037/RC/KEMU

Identifier Type: -

Identifier Source: org_study_id

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