Qualia Vitamin C+ for Vitamin C Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a 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 assigned 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 Is on the Research Team?
Colin Gardner, PhD
Principal Investigator
Qualia Life Sciences
William Scuba
Principal Investigator
Qualia Life Sciences
Sarah Blomquist, PhD
Principal Investigator
Qualia Life Sciences
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 25-75 in the US (except NJ, NY, RI) with either low or adequate vitamin C levels. Participants must be able to visit a lab twice, keep their diet and supplements unchanged during the study, and not have certain health conditions or take specific medications. Pregnant or breastfeeding women cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Qualia Vitamin C+ or placebo daily for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Qualia Vitamin C+
Trial Overview
The study compares Qualia Vitamin C+ capsules to placebo over 28 days to see how they affect blood vitamin C levels in adults with different starting levels. It also looks at effects on fatigue and quality of life using online surveys. Participants are randomly assigned to one group and neither they nor researchers know which product they're taking.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants with suboptimal vitamin C blood levels (0.4 - 0.9 mg/dL) taking two capsules of Qualia Vitamin C+ once daily in the morning, with or without food, for 28 days. 38 participants.
Participants with adequate vitamin C blood levels (≥0.9 mg/dL) taking two capsules of Qualia Vitamin C+ once daily in the morning, with or without food, for 28 days. 38 participants.
Participants with suboptimal vitamin C blood levels (0.4 - 0.9 mg/dL) taking two capsules of placebo (inert rice powder in a vegetable/cellulose capsule) once daily in the morning, with or without food, for 28 days. 38 participants.
Participants with adequate vitamin C blood levels (≥0.9 mg/dL) taking two capsules of placebo (inert rice powder in a vegetable/cellulose capsule) once daily in the morning, with or without food, for 28 days. 38 participants.
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Who Is Running the Clinical Trial?
Qualia Life Sciences
Lead Sponsor
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