Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in 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

Completed

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Key information

Conditions

Hypothyroidism Primary Dyslipidemias Endocrine System Diseases Hypothyroidism Lipid Disorder Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Thyroid Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

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

Drug

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

Other names: Thyroxine

Primary outcomes

Decline in Total Cholesterol

Time frame: 24 weeks

>9% decline from baseline
Decline in LDL

Time frame: 24 weeks

14% decline in LDL-C from baseline >14% decline from baseline

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

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

Acronym: ViDaLLiT

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 23, 2024
Registry last updated: Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed