An interventional study of Qualia Vitamin C+ and Placebo in Healthy, Suboptimal Vitamin C Levels and Adequate Vitamin C Levels, sponsored by Qualia Life Sciences. Recruiting at 1 site in United States. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Qualia Life Sciences · Not applicable, Interventional, and Basic science
Among 704 studies in Fatigue with a site in United States — 92 open to participants now, 114 under way, 10 of them phase 3. Fatigue · United States.
Among the 704 studies in Fatigue with a site in United States, this one is the 119th largest by planned enrollment of the 610 interventional ones, is one of 39 that started in 2026, is one of 414 with no phase, reaches primary completion later than 55 of the 113 other live ones, and was the 684th registered.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's planned enrollment of 152 is above the median of 54 across 1,757 interventional studies indexed under Fatigue.
Browse Fatigue studies →92 of the 704 studies in Fatigue with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 240 Fatigue studies recruiting now, 112 (47%) set no upper age limit and 98 (41%) stop at 75 or younger; 24 take children under 18; 74 take healthy volunteers.
This study: 25 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →704 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 39 started in 2026.
Median enrollment 47 across the 610 interventional studies, 82 across the 86 observational. Of the 537 that completed or were terminated, 174 (32%) have results posted.
84 of 704 have an industry lead sponsor. The 10 most frequent:
Qualia Life Sciences is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Qualia Life Sciences has 1 study filed under Fatigue — fewer than ten, so there is no comparison to draw.
45 of the studies in Fatigue with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT06085716Phase 3M.D. Anderson Cancer CenterCombination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers | 2027-08-31 |
| NCT07500090Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) | 2027-10 |
| NCT07675135Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy | 2027-10 |
Among the 704 studies in Fatigue with a site in United States, from their registry updates:
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.
Design: Double-Blind Placebo-Controlled Parallel 4-Armed Trial (4 arms) with 1:1:1:1 allocation, stratified by gender, age, and baseline vitamin C levels. Arms: (1) Suboptimal Qualia Vitamin C+, (2) Suboptimal Placebo, (3) Adequate Qualia Vitamin C+, and (4) Adequate Placebo. Participants will be stratified by gender and age at screening before being assigned in a 1:1:1:1 ratio to one of the two study arms per stratum. Each participant will take two capsules of their assigned product daily in the morning, with or without food, for 28 consecutive days. Participants will receive a 28-day supply (56 capsules) of their assigned intervention. The active product Qualia Vitamin C+ delivers 500 mg total vitamin C per daily serving (2 capsules) and contains a blend of Vitamin C (from liposomal vitamin C, mineral ascorbates, and fruit extracts), bioflavonoids, and ferulic acid. The placebo contains inert rice powder in a vegetable/cellulose capsule. Blood vitamin C levels will be measured via blood draws through Ulta Labs, which uses licensed blood draw centers operated by Quest Diagnostics. To maintain double-blinding, a designated Qualia Life Sciences staff member independent of the research team will assign and label all study products as A or B. Both participants and study personnel will remain blinded to group assignments until study completion. The primary analysis will be ANCOVA on Day 28 serum vitamin C in the suboptimal stratum, with baseline serum vitamin C, age, and sex as covariates and treatment arm as the factor of interest. Total enrollment: 152.
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Qualia Vitamin C+
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.
Other: Placebo
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.
Dietary Supplement: Qualia Vitamin C+
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.
Other: Placebo
A novel multi-ingredient formulation delivering 500 mg total vitamin C per daily serving (2 capsules). It contains a blend of Vitamin C (from liposomal vitamin C, mineral ascorbates, and fruit extracts), bioflavonoids, and ferulic acid. Participants take two capsules daily in the morning, with or without food, for 28 consecutive days.
Contains inert rice powder in a vegetable/cellulose capsule. Participants take two capsules daily in the morning, with or without food, for 28 consecutive days.
Change in blood Vitamin C levels in the suboptimal stratum
To assess between-group differences in the change in blood Vitamin C levels in the suboptimal stratum from baseline to Day 28 following supplementation with Qualia Vitamin C+ versus placebo. Assessed via Ulta Labs Vitamin C Test (lab blood collection).
Time frame: Baseline to Day 28
Change in blood Vitamin C levels in the entire cohort
To assess between-group differences in the change in blood Vitamin C levels in the entire cohort from baseline to Day 28 following supplementation with Qualia Vitamin C+ versus placebo.
Time frame: Baseline to Day 28
FACIT-Fatigue Scale
To assess within-group and between-group differences in the FACIT-Fatigue Scale in both the sub-optimal vitamin C stratum and the entire cohort. Final score ranges from 0 to 52, where higher scores indicate less fatigue and better quality of life.
Time frame: Baseline to Day 28
RAND-36
To assess within-group and between-group differences in the RAND-36 (primary attention to the Vitality, General Health Perceptions, and Physical Functioning subscales) in both the sub-optimal vitamin C stratum and the entire cohort. Each domain is scored on a 0-100 scale, with higher scores indicating better health.
Time frame: Baseline to Day 28
Single-item Assessment of Immune Fitness
To assess within-group and between-group differences in the Single-item Assessment of Immune Fitness in both the sub-optimal vitamin C stratum and the entire cohort. A single numerical score between 0 and 10 is produced, with higher scores indicating better self-rated immune fitness.
Time frame: Baseline to Day 28
Within-group change in blood Vitamin C levels
To assess within-group differences in the change in blood Vitamin C levels in both the suboptimal stratum and entire cohort.
Time frame: Baseline to Day 28
Proportion of suboptimal group achieving status normalization
To estimate the proportion of the suboptimal group participants achieving plasma vitamin C (≥0.9 mg/dL; i.e., 'status normalization') at Week 4.
Time frame: Week 4
Safety and Tolerability survey
To evaluate side effect profiles using a custom Safety and Tolerability survey.
Time frame: Baseline, Day 7, Day 14, Day 21, and Day 28
Overall Experience Questionnaire
Captures information that may be used for product evaluation and marketing, asked 5-7 days after the final dose of the test product.
Time frame: 5-7 days after final dose (Day 34-36)
NCI Fruits and Vegetable Screener - All-Day Screener
Used to assess fruit and vegetable intake at baseline and study completion, for statistical control purposes only.
Time frame: Baseline and Day 28
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Mar 2027, 7 months after the start.
Of 53 industry-sponsored interventional studies with no phase under Fatigue, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 10. This study's planned 7 months is above that.
Counting every sponsor, half of 989 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: start Jul 2026 → Aug 2026, primary completion Nov 2026 → Mar 2027 and completion Dec 2026 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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