Nutritional supplementation for treating actinic purpura in older adults
The Effect of Nutritional Supplementation on Actinic Purpura: A Pilot Study
This study is testing whether a special vitamin C supplement can help older adults with actinic purpura improve their skin health and reduce bruising.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Standard Process Inc. Industry-sponsored |
| Locations | 1 site (Kannapolis, North Carolina) |
| Trial ID | NCT06840574 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of an 8-week nutritional supplement intervention on actinic purpura, a skin condition prevalent in older adults. Participants aged 55 and older will be randomly assigned to receive either a whole-food based vitamin C supplement or isolated vitamin C supplements. The study will assess changes in skin condition through questionnaires, digital photography, and clinical grading at baseline, 4 weeks, and 8 weeks. The goal is to evaluate the efficacy of the nutritional intervention in improving skin health and reducing bruising.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 55 and older with actinic purpura lesions or a history of such lesions.
Not a fit: Patients with known allergies to the study supplements or those not complying with the study protocol may not benefit.
Why it matters
Potential benefit: If successful, this study could provide a new nutritional approach to improve skin health and reduce bruising in older adults.
How similar studies have performed: While there is limited data on similar nutritional interventions for actinic purpura, the approach of using whole-food supplements is gaining interest in dermatological research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Kannapolis, North Carolina
- Standard Process - Nutrition Innovation Center — Kannapolis, North Carolina, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.