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

NCT06276205 | Completed Phase 3

• 1 other identifier: 1037/RC/KEMU
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Hypothyroidism Primary; Lipid Disorder; Dyslipidemias

Keywords

levothyroxine; Vitamin D; Lipids; Hypothyroidism; Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• Decline in Total Cholesterol

  \>9% decline from baseline

  24 weeks

• Decline in LDL

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

  24 weeks

Study Arms (2)

Vitamin D + Levothyroxine

EXPERIMENTAL

Drug: Vitamin D; Drug: Levothyroxin

Levothyroxine Alone

ACTIVE COMPARATOR

Drug: Levothyroxin

Interventions

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

Vitamin D + Levothyroxine

Levothyroxin DRUG

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

Also known as: Thyroxine

Levothyroxine Alone; Vitamin D + Levothyroxine

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known Atherosclerotic Cardiovascular Disease
• BMI\>35kg/m2
• History of Alcoholism (\>14 units/day)
• History of Beta blocker intake
• Patient taking lipid lowering drugs

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Hypothyroidism; Lipid Metabolism Disorders; Dyslipidemias

Interventions

Vitamin D; Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Endocrinology

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 23, 2024
• Study Start: March 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

PA (1)