Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Completed NCT04894318 - The Effect Of Low-Fat And Low-Cholesterol Dietary Intervention On LDL Sub-Groups In Turkısh Dyslipidemic Patients N/A
Completed NCT04862962 - Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia
Completed NCT04052594 - A Study of LY3475766 in Healthy Participants Phase 1
Active, not recruiting NCT04270084 - Metabolic Optimization Through Diet/Lifestyle Improvements For Youth N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04516291 - A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70) Phase 2
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A
Completed NCT04186780 - Effects of Lentinula Edodes Bars on Dyslipidemia and Oxidative Stress in Cholesterol Individuals: Randomized Study N/A
Not yet recruiting NCT03674333 - Effect of Adding Folic Acid on Lipid Parameters in Population With Dyslipidemias N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A
Terminated NCT01697735 - The Therapeutic Effects of Statins and Berberine on the Hyperlipemia Phase 4
Completed NCT00362908 - Effects of Low and Moderate Fat Diets on Lipids, Inflammation and Vascular Reactivity in the Metabolic Syndrome N/A
Completed NCT00455325 - Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS) Phase 2
Completed NCT00644709 - A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD) Phase 4
Recruiting NCT05624658 - Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS N/A
Recruiting NCT03988101 - Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event Phase 4
Recruiting NCT06024291 - Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Trial N/A
Completed NCT01218204 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin Phase 2