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

Last updated: May 12, 2025
Sponsor: Standard Process Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Low Dose Vitamin C

High Dose Vitamin C

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

Clinical Study ID

NCT06840574
SP0022 Cyruta Plus
  • Ages > 55
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female individuals aged ≥ 55 years old.

  • Self-reported having actinic purpura lesions at the time of enrollment or a historyof actinic purpura lesions.

  • Self-reported not using prescription or over-the-counter products that containaluminum, iron, proton pump inhibitors (PPIs), and/or topical retinol (used locallyin areas of bruising).

  • If on a chronic medication that does not result in exclusion, participant mustself-report being on a stable dose for the last 3 months prior to the start of thetrial.

  • 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

Exclusion Criteria:

  • Not complying with the study protocol.

  • Having a known allergy or intolerance to nuts, seeds, fruits, vegetables, oils, andfish.

  • Having a known allergy, intolerance, or dietary restriction to any of the studyingredients (Vitamin C, organic buckwheat (aerial parts) juice powder, organicbuckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid,and calcium stearate).

  • Having a clinically significant condition that is severe, progressive, oruncontrolled and would compromise the study or their well-being or would prevent theparticipant from meeting or performing study requirements. This includes but is notlimited to dysphagia (or difficulty swallowing), liver or kidney disease, bonemarrow problems, Ehlers-Danlos syndrome, lupus, alcohol misuse, cancer, or HIV andother infections.

  • Having active dermatological conditions. Patients with active, severe skinconditions that might interfere with the study's conduct or outcomes includingwidespread psoriasis, untreated chronic skin ulcers, or other severe dermatologicaldisorders.

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Low Dose Vitamin C
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Standard Process - Nutrition Innovation Center

    Kannapolis, North Carolina 28081
    United States

    Active - Recruiting

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