RECRUITING

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

Conditions

Skin Health Skin Aging of Face and Hands Healthy Ecchymosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-01

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06840574

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

Standard Process - Nutrition Innovation Center

Kannapolis, North Carolina, 28081

United States

Collaborators and Investigators

Sponsor: Standard Process Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2025-04-01

Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

Skin Health
Skin Aging of Face and Hands
Healthy
Ecchymosis