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

NCT ID: NCT06840574

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Cyruta Plus

Total of 27 mg daily

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Low-dose Vitamin C

Total of 27 mg daily

Group Type: ACTIVE_COMPARATOR

Low Dose Vitamin C

Intervention Type: DIETARY_SUPPLEMENT

27 mg ascorbic acid

High-dose Vitamin C

Total of 500 mg daily

Group Type: ACTIVE_COMPARATOR

High Dose Vitamin C

Intervention Type: DIETARY_SUPPLEMENT

500 mg ascorbic acid

Interventions

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

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

Intervention Type: DIETARY_SUPPLEMENT

Low Dose Vitamin C

27 mg ascorbic acid

Intervention Type: DIETARY_SUPPLEMENT

High Dose Vitamin C

500 mg ascorbic acid

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Standard Process Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Standard Process - Nutrition Innovation Center

Kannapolis, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Amy Kock

Role: primary

aklock@standardprocess.com

704-706-6729

Other Identifiers

SP0022 Cyruta Plus

Identifier Type: -

Identifier Source: org_study_id