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The Impact of Qualia Vitamin C+ on Blood Vitamin C Levels

NCT ID: NCT07285109

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-22

Study Completion Date

2026-02-11

Brief Summary

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This is a randomized, double-blind, placebo-controlled, parallel-group, study evaluating the effect of a Qualia Vitamin C+ formulation on Whole Blood Vitamin C levels in the blood of healthy adults aged 25 years or older. Approximately 36 participants will be randomized to one of two study arms: Qualia Vitamin C+ or placebo. Each participant will take two capsules of their assigned product once daily in the morning, with or without food, over a 28-day period. The primary outcome is the change in blood vitamin C levels, assessed via in lab blood collection at baseline and study completion. Secondary endpoints include questionnaires measuring health-related cognitive functioning and stress (PROMIS Cognitive Function - Short Form 8a and the Perceived Stress Scale-10), the Single-item Assessment of Immune Fitness, evaluation of safety and tolerability, and an Overall Experience Questionnaire (Appendices 1, 4-7). All assessments, including electronic questionnaires, are completed remotely without in-person visits.

Detailed Description

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Conditions

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Vitamin C Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Qualia Vitamin c+

Qualia Vitamin C+ manufactured by Qualia Life Sciences

Group Type ACTIVE_COMPARATOR

Qualia Vitamin C+

Intervention Type DIETARY_SUPPLEMENT

Qualia Vitamin C+ manufactured by Qualia Life Sciences

Placebo

Rice flour placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Rice flour

Interventions

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Qualia Vitamin C+

Qualia Vitamin C+ manufactured by Qualia Life Sciences

Intervention Type DIETARY_SUPPLEMENT

Placebo

Rice flour

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Provide voluntary, written, informed consent to participate in the study. Agree to provide a valid cell phone number and are willing to receive communications through text.

Can read and write English. Willing to complete questionnaires, records, and diaries associated with the study.

Healthy male and female participants aged 25 years or older. Willing to go to an Ulta Labs Patient Service Center location for a Blood Vitamin C Test (baseline and Day 29) and located within a convenient distance of participating locations. \[Note: The services offered by Ulta Lab Tests are available only in the United States and not to residents of the states of New Jersey, New York, and Rhode Island.\] Willing to avoid starting new or stopping any existing dietary supplements throughout the study.

Exclusion Criteria

Women who are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the trial.

Known food intolerances/allergy to any ingredients in the product. Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer.

Having had a significant cardiovascular event in the past 6 months. Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines On immunosuppressive therapy. Adults lacking capacity to consent.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Qualia Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qualia Life Sciences

Carlsbad, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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William Scuba

Role: CONTACT

[email protected]
855-281-2328

Facility Contacts

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Study Coordinator

Role: primary

[email protected]
855-281-2328

Other Identifiers

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QLS-020

Identifier Type: -

Identifier Source: org_study_id