The Effect of Nutritional Supplementation on Actinic Purpura: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
Purpura is a macule or papule of blood in the skin. It is mostly seen in mature skin that is often prone to significant bruising. Small lesions of less than 5 mm are called petechiae and larger ones, found mostly in subcutaneous tissue, are called ecchymosis. Actinic purpura occurs almost exclusively in elderly populations. This single-blind randomized clinical trial evaluates the effect of an 8-week nutritional supplement intervention in comparison with isolated vitamin C supplements on actinic purpura in older adults. We will enroll thirty (30) otherwise healthy participants, both male and female, aged 55 years and older. Changes in participants' skin condition will be assessed at visit 1 (baseline), visit 2 (4-week), and visit 3 (8-week) using questionnaires, standard digital photography, and clinical grading of the skin lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female individuals aged ≥ 55 years old.
- •Self-reported having actinic purpura lesions at the time of enrollment or a history of actinic purpura lesions.
- •Self-reported not using prescription or over-the-counter products that contain aluminum, iron, proton pump inhibitors (PPIs), and/or topical retinol (used locally in areas of bruising).
- •If on a chronic medication that does not result in exclusion, participant must self-report being on a stable dose for the last 3 months prior to the start of the trial.
- •Able and willing to read and voluntarily sign the study Informed Consent Form (ICF).
- •Able and willing to comply with study protocol and all study-related guidelines.
- •Not concomitantly participating in a study involving nutritional products.
排除标准
- •Not complying with the study protocol.
- •Having a known allergy or intolerance to nuts, seeds, fruits, vegetables, oils, and fish.
- •Having a known allergy, intolerance, or dietary restriction to any of the study ingredients (Vitamin C, organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, and calcium stearate).
- •Having a clinically significant condition that is severe, progressive, or uncontrolled and would compromise the study or their well-being or would prevent the participant from meeting or performing study requirements. This includes but is not limited to dysphagia (or difficulty swallowing), liver or kidney disease, bone marrow problems, Ehlers-Danlos syndrome, lupus, alcohol misuse, cancer, or HIV and other infections.
- •Having active dermatological conditions. Patients with active, severe skin conditions that might interfere with the study's conduct or outcomes including widespread psoriasis, untreated chronic skin ulcers, or other severe dermatological disorders.
研究组 & 干预措施
Cyruta Plus
Total of 27 mg daily
干预措施: Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid (Dietary Supplement)
Low-dose Vitamin C
Total of 27 mg daily
干预措施: Low Dose Vitamin C (Dietary Supplement)
High-dose Vitamin C
Total of 500 mg daily
干预措施: High Dose Vitamin C (Dietary Supplement)
结局指标
主要结局
Primary Endpoint
时间窗: 8 weeks
The number of participants who report a reduction in the number of purpura lesions as evaluated through dermatological examination before and after supplementation.
次要结局
- Secondary Endpoint(8 weeks)