Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in visual function
研究概览
简要总结
This study will evaluate the effects of a novel multi-component dietary supplement on the visual function and retinal structure of patients with diabetes with both no diabetic retinopathy and mild to moderate diabetic retinopathy. This is a placebo-controlled trial and neither subjects nor examiners will know if any given subject is taking active supplement or placebo.
The hypothesis is that the supplement will improve visual function and retinal structure in subjects on active supplement
详细描述
Adult patients with either type 1 or type 2 diabetes will be enrolled with baseline measurement of visual acuity, contrast sensitivity, color vision, threshold macular perimetry, macular pigment optical density, optical coherence tomography, glycosylated hemoglobin, blood lipids and serum vitamin D status. A multi-component dietary supplement containing ingredients currently available over the counter in the US will be taken for six months and repeat measurements of the above parameters obtained.
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
- 否
入选标准
- •diabetes mellitus diagnosed at least 5 years
- •age greater than or equal to 18 years
- •English speaker
排除标准
- •proliferative diabetic retinopathy or severe non-proliferative retinopathy
- •clinically significant macular edema
- •corrected visual acuity less than 20/30 in either eye
- •diagnosis of other serious eye disease (glaucoma, age-related maculopathy)
- •less than 18 years old
- •non-English speaker
- •no known allergy or sensitivity to any supplement ingredients
研究组 & 干预措施
supplement - no retinopathy
subjects receiving active supplement and with no retinopathy based on clinical examination
干预措施: multi-component nutritional supplement capsules (Dietary Supplement)
placebo - no retinopathy
patients receiving placebo and who have no diabetic retinopathy based on clinical examination
干预措施: multi-component dietary supplement (Dietary Supplement)
supplement - retinopathy
patients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
干预措施: multi-component nutritional supplement capsules (Dietary Supplement)
placebo - retinopathy
patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
干预措施: multi-component dietary supplement (Dietary Supplement)
结局指标
主要结局
Changes in visual function
时间窗: At baseline and again at six months
Change in contrast sensitivity, color vision and macular perimetry thresholds
次要结局
- Changes in serum markers(At baseline and again at six months)
- Changes in retinal structure(At baseline and again at 6 months)