Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism (ViDaLLiT)

March 7, 2025 updated by: Sidrah Lodhi, King Edward Medical University

To Compare the Effectiveness of Vitamin D & Levothyroxine Combination Therapy and Levothyroxine Alone on Serum Lipid Profile in Patients With Hypothyroidism

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • King Edward Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D + Levothyroxine
Drug: 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

Drug: Levothyroxin
commenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response
Other Names:
  • Thyroxine
Active Comparator: Levothyroxine Alone
Drug: Levothyroxin
commenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response
Other Names:
  • Thyroxine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decline in Total Cholesterol
Time Frame: 24 weeks
>9% decline from baseline
24 weeks
Decline in LDL
Time Frame: 24 weeks
14% decline in LDL-C from baseline >14% decline from baseline
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1037/RC/KEMU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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