Hypothyroidism Primary, Lipid Disorder, Dyslipidemias
Conditions
Keywords
levothyroxine, Vitamin D, Lipids, Hypothyroidism, Dyslipidemia
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
Interventions
DRUGVitamin 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
DRUGLevothyroxin
commenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response
Sponsors
King Edward Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decline in Total Cholesterol | 24 weeks | \>9% decline from baseline |
| Decline in LDL | 24 weeks | 14% decline in LDL-C from baseline \>14% decline from baseline |
Countries
Pakistan
Outcome results
None listed