Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism
NCT ID: NCT06276205
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
62 participants
INTERVENTIONAL
2024-03-01
2025-01-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vitamin D + Levothyroxine
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
Levothyroxine Alone
Levothyroxin
commenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* BMI\>35kg/m2
* History of Alcoholism (\>14 units/day)
* History of Beta blocker intake
* Patient taking lipid lowering drugs
12 Years
ALL
No
Sponsors
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King Edward Medical University
OTHER
Responsible Party
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Sidrah Lodhi
Assistant Professor of Endocrinology
Locations
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King Edward Medical University
Lahore, Punjab Province, Pakistan
Countries
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Other Identifiers
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1037/RC/KEMU
Identifier Type: -
Identifier Source: org_study_id
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