Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neurological recovery,metabolic profile and Antioxidant profile evaluation
研究概览
简要总结
The objective of this study is to evaluate the effect of omega 3 fatty acid on neurological recovery, lipid profile and Antioxidant system in patients with spinal cord injury. One hundred spinal cord injured patients who come to clinic of spinal injury repair research center selected. Then the patients will receive two supplements capsules of omega 3 (600 mg) in the intervention group and placebo in the control group. Primary outcome measures are professionals evaluation of neurological function by using :
- ASIA scale for sensory and motor function
- FIM scale for Functional potential
- FAM
- SF_36 for quality of life
Lipid profile and Antioxidant profile evaluation by using:
- FBS
- 2hpp
- Insulin
- LDL
- Total cHOL
- TG
- HDL
- Leptin Adiponectin -Calcium-
- 25OHD
- PTH,LH, FSH, Prolactin,Testosterone in males Bone markers by serum levels of :Osteocalcin-Osteoprotegrin_Bone Specified ALP- CTX - RANKL
- BMD
详细描述
All no neurological evaluation will be done by experiment researcher under considering of a neurologist.All Sub clinical evaluation will be done by specific, sensitive and valid laboratory methods. Intervention time will be 14 months.Comparison of these variables will be done before and after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no metabolic, malignant or kidney disorder, normal TSH, LH, FSH, prolactin, and testosterone in men and normal prolactin, estradiol, LH, FSH, and TSH in women
排除标准
- •pregnancy, lactation, presence of bone disease,hypersensitivity to fish or fish oil, hypertension
结局指标
主要结局
Neurological recovery,metabolic profile and Antioxidant profile evaluation
时间窗: 4 months
Primary outcome measures are professionals evaluation of neurological function by using : * Osteocalcin * osteoprotegrin * Bone Specified ALP * CTX * RANKL
Neurological recovery,metabolic profile and Antioxidant profile evaluation in SCI patients
时间窗: 14 months
ASIA scale for sensory and motor function FIM scale for Functional potential FAM SF36 for quality of life by using: FBS 2hpp Insulin LDL Total cHOL TG HDL Leptin Adiponectin -Calcium- 25OHD PTH,LH, FSH, Prolactin,Testosterone in males
次要结局
- Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI(14 months)