Vitamin D & Levothyroxine Combination Versus Levothyroxin... | NCT06276205

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

NCT06276205

Sponsor

King Edward Medical University

Status

Completed

Last Update Posted

Mar 11, 2025Actual

Enrollment

62Actual

Phase

Phase 3

Conditions

Hypothyroidism Primary
Lipid Disorder
Dyslipidemias

Interventions

Vitamin D
Levothyroxin

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Jan 1, 2025Actual

Completion Date

Jan 1, 2025Actual

First Submitted Date

Feb 17, 2024

First Submission Date that Met QC Criteria

Feb 17, 2024

First Posted Date

Feb 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2025

Last Update Posted Date

Mar 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sidrah Lodhi, Assistant Professor of Endocrinology, King Edward Medical UniversityPrincipal Investigator

Lead Sponsor

King Edward Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D + Levothyroxine	Experimental		Drug: Vitamin D Drug: Levothyroxin
Levothyroxine Alone	Active Comparator		Drug: Levothyroxin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Edward Medical University		Lahore	Punjab Province	54000	Pakistan

Condition Browse Module

MeSH Terms

ID	Term
D007037	Hypothyroidism
D052439	Lipid Metabolism Disorders
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D
D013974	Thyroxine

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided