To Compare the Effectiveness of Vitamin D & Levothyroxine Combination Therapy and Levothyroxine Alone on Serum Lipid Profile in Patients With Hypothyroidism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Decline in Total Cholesterol
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Known Atherosclerotic Cardiovascular Disease
- •BMI>35kg/m2
- •History of Alcoholism (>14 units/day)
- •History of Beta blocker intake
- •Patient taking lipid lowering drugs
研究组 & 干预措施
Vitamin D + Levothyroxine
干预措施: Vitamin D (Drug)
Vitamin D + Levothyroxine
干预措施: Levothyroxin (Drug)
Levothyroxine Alone
干预措施: Levothyroxin (Drug)
结局指标
主要结局
Decline in Total Cholesterol
时间窗: 24 weeks
\>9% decline from baseline
Decline in LDL
时间窗: 24 weeks
14% decline in LDL-C from baseline \>14% decline from baseline
次要结局
未报告次要终点
研究者
Sidrah Lodhi
Assistant Professor of Endocrinology
King Edward Medical University