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

King Edward Medical University

Status and phase: Completed; Phase 3

Conditions: Lipid Disorder; Dyslipidemias; Hypothyroidism Primary

Treatments: Drug: Vitamin D; Drug: Levothyroxin

Study type: Interventional

Funder types: Other

Identifiers

NCT06276205

1037/RC/KEMU

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Vitamin D + Levothyroxine

Experimental group

Treatment:

Drug: Levothyroxin

Drug: Vitamin D

Levothyroxine Alone

Active Comparator group

Treatment:

Drug: Levothyroxin