IRCT2014050317534N1已完成2 期
Clinical trial to evaluate the effect of vitamin D supplementation on discogenic pain and sensory deficits associated with cases afflicted with lumbar disc herniation
Vice Chancellor for Research Shiraz University of Medical Sciences0 个研究点目标入组 380 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 380
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 60 years(—)
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1) No coexistent or preexisting spine pathology (e.g. Spondylolisis, Spondylolisthesis, Infection, Tumors, Fracture);
- •2) Single level lumbar disc herniation;
- •3) Discogenic pain duration from onset up physician evaluation: less than 8 weeks;
- •4) Compliance with study protocol;
- •5) Normal Lab studies;
排除标准
- •1) Daily supplementation intake of more than 800 IU of vitamin D;
- •2) Serum calcium level more than 10.5 md/dl;
- •3) Hypercalciuria ( spot urine calcium creatinin ratio more than 0.4);
- •4) Lymphoma, Sarcoidosis, TB, Hyperparathyroidism, Celiac disease, malabsorption syndromes;
- •5) Hx of renal stone;
- •6) Hx of inflammatory back pain;
- •7) Impaired renal function tests (GFR less than 30);
- •8) Impaired hepatic function tests;
- •9) Abnormal Serum Phosphorus, Alkaline phosphatase and Parathyroid hormone values;
- •10) FBS more than 126;
- •11) Previous spine surgery;
- •12) Hx of trauma;
- •13) Taking Anticonvulsant, Anti-TB medications or vitamin D analogs;
- •14) Cauda Equina syndrome that requires emergency surgical decompression.
研究者
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