The Effect of Nutritional Supplementation on Actinic Purpura: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: t
View:

• 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.

Locations
United States
North Carolina
Standard Process - Nutrition Innovation Center
RECRUITING
Kannapolis
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 30
Treatments
Experimental: Cyruta Plus
Total of 27 mg daily
Active_comparator: Low-dose Vitamin C
Total of 27 mg daily
Active_comparator: High-dose Vitamin C
Total of 500 mg daily
Related Therapeutic Areas
Sponsors
Leads: Standard Process Inc.

This content was sourced from clinicaltrials.gov

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