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NCT06276205 Clinical Trial

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

Dyslipidemias Clinical Trial

— ViDaLLiT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06276205
Other study ID # 1037/RC/KEMU
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 1, 2024
Est. completion date September 30, 2024

Study information
Verified date February 2024
Source King Edward Medical University
Contact Sidrah Lodhi
Phone 03004683473
Email sidrah.lodhi@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Pakistan King Edward Medical University Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decline in Total Cholesterol >9% decline from baseline 24 weeks
Primary Decline in LDL 14% decline in LDL-C from baseline7 >14% decline from baseline 24 weeks
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