The Impact of Qualia Vitamin C+ on Individuals With Suboptimal and Adequate Vitamin C Levels (NCT07652346) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Impact of Qualia Vitamin C+ on Individuals With Suboptimal and Adequate Vitamin C Levels
United States152 participantsStarted 2026-07
Plain-language summary
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 that have suboptimal vitamin C blood levels (i.e., 0.4 - 0.9 mg/dL) and those with adequate vitamin C blood levels (≥0.9 mg/dL). Approximately 152 (76 in the suboptimal stratum and 76 in the adequate stratum) 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 in the suboptimal stratum, assessed via lab blood collection at baseline and study completion. Secondary endpoints include the change in blood vitamin C levels, assessed via lab blood collection at baseline and study completion in the entire group, questionnaires measuring health-related Quality of Life and fatigue (RAND-36 and the FACIT-Fatigue Scale), the Single-item Assessment of Immune Fitness, evaluation of safety and tolerability, and an Overall Experience Questionnaire. Further, a sub-group analysis of fatigued participants meeting at least mild to moderate fatigue as measured by the FACIT-Fatigue will be a secondary objective. The NCI Fruits and Vegetable Screener - All-Day Screener will also be used to assess intake at baseline and study completion. All assessments, including electronic questionnaires, are completed remotely without in-person visits.
Who can participate
Age range
25 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 to 75 years old.
* 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. 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.
* Willing to maintain a consistent diet 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a product called Qualia Vitamin C+ in people who already have either suboptimal or adequate vitamin C levels — given my current vitamin C status, would I even fall into one of those groups, and is that something worth checking before considering a trial like this?
2The trial hasn't started recruiting yet — do you think it's worth waiting to see if I qualify once it opens, or is there something I could be doing right now to address my vitamin C levels in the meantime?
3Since this is a Phase NA nutritional supplement study, what does that mean for how much we'd already know about its safety compared to a standard pharmaceutical trial — and are there any risks you'd want me to be aware of before I consider a supplement intervention like this?
4The trial's main goal is to measure changes in blood vitamin C levels, but it's not clear it's measuring how I'd feel day-to-day — is improving a blood marker alone likely to translate into any meaningful health benefit for someone in my situation?
5Could I just take a regular vitamin C supplement on my own instead of joining a study like this, and how would we know whether that would be just as effective as whatever this Qualia product is being tested for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in blood Vitamin C levels in the suboptimal stratum