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

Phase 3
Completed
Conditions
Hypothyroidism Primary
Lipid Disorder
Dyslipidemias
Interventions
Registration Number
NCT06276205
Lead Sponsor
King Edward Medical University
Brief Summary

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

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
62
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Vitamin D + LevothyroxineLevothyroxin-
Vitamin D + LevothyroxineVitamin D-
Levothyroxine AloneLevothyroxin-
Primary Outcome Measures
NameTimeMethod
Decline in Total Cholesterol24 weeks

\>9% decline from baseline

Decline in LDL24 weeks

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

King Edward Medical University

🇵🇰

Lahore, Punjab, Pakistan

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