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

NCT06840574 | Suspended

• 1 other identifier: SP0022 Cyruta Plus
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Health; Skin Aging of Face and Hands; Healthy; Ecchymosis

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The number of participants who report a reduction in the number of purpura lesions as evaluated through dermatological examination before and after supplementation.

  8 weeks

Secondary Outcomes (1)

• Secondary Endpoint

  8 weeks

Study Arms (3)

Cyruta Plus

EXPERIMENTAL

Total of 27 mg daily

Dietary Supplement: 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

Low-dose Vitamin C

ACTIVE COMPARATOR

Total of 27 mg daily

Dietary Supplement: Low Dose Vitamin C

High-dose Vitamin C

ACTIVE COMPARATOR

Total of 500 mg daily

Dietary Supplement: High Dose Vitamin C

Interventions

Low Dose Vitamin C DIETARY_SUPPLEMENT

27 mg ascorbic acid

Low-dose Vitamin C

High Dose Vitamin C DIETARY_SUPPLEMENT

500 mg ascorbic acid

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 DIETARY_SUPPLEMENT

27 mg vitamin C, organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, and calcium stearate

Cyruta Plus

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Standard Process Inc.: lead

Study Sites (1)

Standard Process - Nutrition Innovation Center

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Ecchymosis

Interventions

Honey; Ascorbic Acid

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 21, 2025
• Study Start: April 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)