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

King Edward Medical University62 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypothyroidism Primary Lipid Disorder Dyslipidemias

Interventions

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

LevothyroxinDRUG

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

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

King Edward Medical University

Lahore, Punjab Province, Pakistan

Outcomes

Primary Outcomes

Decline in Total Cholesterol

\>9% decline from baseline

Time frame: 24 weeks

Decline in LDL

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

Time frame: 24 weeks

Data from ClinicalTrials.gov

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