ACTRN12618000705280已完成2 期
A proof-of-concept, placebo-controlled trial to evaluate the effects of omega-3 fatty acid supplementation on peripheral nerve health in type-1 diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Provision of written informed consent to participate
- •Confirmed diagnosis of type-1 diabetes for at least five years
- •Ability to understand and follow study instructions, and intent to complete all study visits
排除标准
- •Uncontrolled systemic disease (other than sub-optimally controlled diabetes mellitus)
- •Confirmed neuropathy secondary to causes other than diabetes
- •Co-morbid ocular pathology (e.g., ocular infection, intra-ocular inflammation) or presence of corneal abnormalities that could distrupt normal corneal nerve morphology
- •Known allergy to or previous reaction to any ocular agents used in the study (i.e., ocular anaesthetics, sodium fluorescein, ocular mydriatics)
- •Scheduled or planned ocular surgery or procedure over the course of the study
- •Any history of hard (rigid) contact lens wear
- •Use of autologous serum eye drops within three (3) months of enrolment, or anticipated use during the course of the study;
- •Known or suspected allergy to fish/seafood, nuts, oil or gelatin
- •Current or previous regular consumption of any omega-3 oral supplements (>3 times/week) in the three months preceding Visit 1
- •A systemic medical condition where omega-3 supplements are contraindicated (e.g., bleeding disorders, diabetes, atrial fibrillation, familial immunocompromise, adenomatous polyposis, liver disease.)
研究者
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