HealthyNCT06471023
A Pharmacokinetic Study of Single Oral Doses of Six Different Vitamin C Product Forms
A study testing TP1, TP2 and TP3 in people with Healthy and Pharmacokinetic, run by dsm-firmenich Switzerland AG at 1 site in Canada.
Trial summary
Vitamin C (ascorbic acid) is an essential nutrient linked to many aspects of basic human physiology. It is a potent antioxidant and involved as a cofactor for many human enzymes, and its extreme deficiency can lead to a fatal disease known as scurvy and reduce immune function. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetic
- What is being tested?
- TP1, TP2 and TP3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2024to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator.
- Are able to swallow the study products, in whole.
- Have a body mass index (BMI) between 18.0 to 29.9 kg/m2 (inclusive).
- Must have suitable veins for repeated venipuncture.
- No nicotine and/or nicotine products, including smoking or vaping of any kind (e.g., cigarettes) for at least 3 months before screening.
- Have maintained consistent dietary habits (including supplement intake) and lifestyle for the last 3 months before screening. Participants must be willing to maintain these habits throughout the duration of the study, with the exception of changes required by the vitamin C dietary restrictions.
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- Willing to comply with the vitamin C dietary restrictions, 2 weeks prior to the baseline and throughout the duration of the study until the last study visit.
- Agree to follow the restrictions on concomitant treatments as listed in the protocol.
- Agree to follow the restrictions on lifestyle as listed in the protocol.
- Agree to use acceptable contraceptive methods as listed in the protocol.
- Willing and able to agree to the requirements of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures.
- Agrees not to donate blood until 3 months after study completion
- Must weigh ≥ 58.9 kg (130 lbs) at screening
Who cannot join
- Individuals who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- Have Type I diabetes, Type II diabetes, high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or thyroid disease.
- Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
- Have a history of heart disease, renal or hepatic impairment/disease, gout, hemochromatosis, glucose-6-phosphate dehydrogenase deficiency, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
- Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless a minimum of 5 years before the screening visit have elapsed since full recovery.
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- Reports a clinically significant illness during the 28 days before the first dose of study product, including acute inflammatory conditions or viral infections (e.g., cold, flu, COVID-19), or any other condition that, in the opinion of the investigator, may be of a concern for the study.
- Participants must not exceed the ''high'' physical activity level as defined by the International Physical Activity Questionnaire-- Short Form (IPAQ-SF) in the week prior to baseline and agree to adhere to this requirement throughout the study duration. A 'high' physical activity level is defend as having engaged in vigorous-intensity physical activity on at least 3 days achieving a total of 1500 or more Metabolic Equivalent of Task (MET)-minutes per week; or, having engaged in any combination of walking, moderate-intensity, or vigorous-intensity physical activities on 7 or more days achieving a total of 3000 or more MET-minutes per week.
- Reports a significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to the first PK visit or a blood donation of more than 450 mL within 3 months prior to the first PK visit.
- Major surgery in 3 months before screening or planned major surgery during the study.
- Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
- Demonstrates a positive urine drug screen for compounds listed in the protocol, or positive breath alcohol test at screening or baseline.
- Have a history of alcohol or substance abuse in the 12 months before screening (including having been hospitalized for such in an in-patient or out-patient intervention program).
- Currently consumes, on average, more than 2 standard alcoholic beverages a day or has any habit of alcohol use that, to the opinion of the investigator, may be of a concern for the study. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.
- Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 30 days before first dose of study product (or screening) or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Crossover, Pharmacokinetic Assessment of Single Oral Doses of Six Different Vitamin C Product Forms
Vitamin C (ascorbic acid) is an essential nutrient linked to many aspects of basic human physiology. It is a potent antioxidant and involved as a cofactor for many human enzymes, and its extreme deficiency can lead to a fatal disease known as scurvy and reduce immune function. Relatively less serious deficiency over a longer period of time may also increase cardiovascular disease and cancer risk. Deficiency is common amongst the Canadian general population, with around 5.5% being found to possess deficient plasma concentrations. Moreover, amongst many industrialized countries, rates of deficiency can be as high as 15% of the general population. Potential vitamin C overdose is not considered to be serious, but symptoms can include nausea, vomiting, headache, rash, and asthenia.
The pharmacokinetic profiles of vitamin C supplements are influenced by their formulation, impacting safety and efficacy. The study will compare the PK properties of six different vitamin C formulations, each over a 24 h test period.
Read the detailed description
This is a randomized, 6-way crossover pharmacokinetic study to assess 6 different vitamin C formulations in healthy adults.
There is 1 comparator product (CP), 1 reference product (RP), and 4 test products (TP: TP1, TP2, TP3, TP4):
- TP1 (Vitamin C formulation 1, 1000 mg)
- TP2 (Vitamin C formulation 2, 1000 mg)
- TP3 (Vitamin C formulation 3, 1000 mg)
- TP4 (regular Vitamin C mega dose, 3000 mg)
- CP (Vitamin C formulation 4, 1000 mg)
- RP (regular Vitamin C, 1000 mg)
Each sequence will have 9 participants for a total of 27 participants.
- Sequence 1: TP1 → TP2 → TP3 → TP4 → CP → RP
- Sequence 2: RP → TP1 → TP2 → TP3 → TP4 → CP
- Sequence 3: CP → RP → TP1 → TP2 → TP3 → TP4
Pharmacokinetic blood sampling will occur pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 h post dose. Blood samples collected will be used to assess the PK profiles of all 6 formulations. PK parameters measured will include AUC0-24, Cmax, Tmax, AUCinf, T1/2, and Kel for L-ascorbic acid. L-ascorbic acid concentrations will be measured in urine to compare excretion during 0-4 h, 4-8 h, 8-10 h, and 10-24 h post-dose between all 6 formulations. L-ascorbic acid will also be measured in peripheral blood mononuclear cells at 8 h and 24 h post-dose to compare uptake and maintenance between all 6 formulations.
Gastrointestinal symptom questionnaire scores and total antioxidant capacity in plasma at 24 hours post-dose will also be compared between all 6 formulations.
Safety endpoints will be assessed throughout the study and will include reports of adverse events, vital signs, and safety laboratory assessments.
- Conditions
- Healthy, Pharmacokinetic
- Being tested
- TP1, TP2, TP3, TP4, CP
- Keywords
- Vitamin C, Ascorbic acid, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP1Dietary supplement
Vitamin C formulation 1, 1000 mg
TP2Dietary supplement
Vitamin C formulation 2, 1000 mg
TP3Dietary supplement
Vitamin C formulation 3, 1000 mg
TP4Dietary supplement
regular Vitamin C, 3000 mg
CPDietary supplement
Vitamin C formulation 4, 1000 mg
RPDietary supplement
regular Vitamin C, 1000 mg
| Study group | Role | What they receive |
|---|---|---|
| TP1 → TP2 → TP3 → TP4 → CP → RP | Other | Each test period will consist of 2 in-clinic visits to assess the pharmacokinetics of one of the assigned study products. On Day 1 of each test period participants will provide a pre-dose blood sample within 90-minutes before a dose of study product, followed by PK blood sample collections for the next 10 h. Participants will return to the clinic the following day for the 24 h PK blood sample collection. Each test period will be separated by a washout period. Receives: Dietary Supplement: TP1; Dietary Supplement: TP2; Dietary Supplement: TP3; Dietary Supplement: TP4; Dietary Supplement: CP; Dietary Supplement: RP |
| RP → TP1 → TP2 → TP3 → TP4 → CP | Other | Each test period will consist of 2 in-clinic visits to assess the pharmacokinetics of one of the assigned study products. On Day 1 of each test period participants will provide a pre-dose blood sample within 90-minutes before a dose of study product, followed by PK blood sample collections for the next 10 h. Participants will return to the clinic the following day for the 24 h PK blood sample collection. Each test period will be separated by a washout period. Receives: Dietary Supplement: TP1; Dietary Supplement: TP2; Dietary Supplement: TP3; Dietary Supplement: TP4; Dietary Supplement: CP; Dietary Supplement: RP |
| CP → RP → TP1 → TP2 → TP3 → TP4 | Other | Each test period will consist of 2 in-clinic visits to assess the pharmacokinetics of one of the assigned study products. On Day 1 of each test period participants will provide a pre-dose blood sample within 90-minutes before a dose of study product, followed by PK blood sample collections for the next 10 h. Participants will return to the clinic the following day for the 24 h PK blood sample collection. Each test period will be separated by a washout period. Receives: Dietary Supplement: TP1; Dietary Supplement: TP2; Dietary Supplement: TP3; Dietary Supplement: TP4; Dietary Supplement: CP; Dietary Supplement: RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of vitamin C compared between each of the liposomal formulations TP1 and TP2 to the traditional RP
Area under the plasma concentration-time curve over 24 h (AUC0-24) for L-ascorbic acid following single dose administration of TP1 and TP2 and RP.
Measured: 0-24 hours
Secondary outcomes (5)
Pharmacokinetics (PK) of single doses of six vitamin C formulations
Peak plasma concentration (Cmax)
Measured: 0-24 hours
Pharmacokinetics (PK) of single doses of six vitamin C formulations
Time to reach Cmax (Tmax)
Measured: 0-24 hours
Bioavailability of vitamin C compared between six different formulations.
AUC0-24 for L-ascorbic acid of six different vitamin C formulations.
Measured: 0-24 hours
Excretion of vitamin C in urine over a 24 h period compared between six different formulations.
L-ascorbic acid excreted in urine over 24 h post-dose and at intervals 0 - 4 h, 4 - 8 h, 8 - 10 h, and 10 - 24 h post-dose
Measured: 0-24 hours
Uptake and maintenance of vitamin C in peripheral blood mononuclear cells (PBMCs) between six different formulations.
L-ascorbic acid concentration in PBMCs normalized to cell count (10^8 cells) pre-dose, 8 h, and 24 h post-dose
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jul 2024
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471023
- Sponsor's protocol ID
- T0052
- Status last verified
- Jan 2025
- First submitted
- 12 Jun 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover, Pharmacokinetic Assessment of Single Oral Doses of Six Different Vitamin C Product Forms
- ClinicalTrials.gov ID
- NCT06471023
- Acronym / sponsor ID
- T0052
- Conditions
- Healthy, Pharmacokinetic
- Keywords
- Vitamin C, Ascorbic acid, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin C (ascorbic acid) is an essential nutrient linked to many aspects of basic human physiology. It is a potent antioxidant and involved as a cofactor for many human enzymes, and its extreme deficiency can lead to a fatal disease known as scurvy and reduce immune function. Relatively less serious deficiency over a longer period of time may also increase cardiovascular disease and cancer risk. Deficiency is common amongst the Canadian general population, with around 5.5% being found to possess deficient plasma concentrations. Moreover, amongst many industrialized countries, rates of deficiency can be as high as 15% of the general population. Potential vitamin C overdose is not considered to be serious, but symptoms can include nausea, vomiting, headache, rash, and asthenia.
The pharmacokinetic profiles of vitamin C supplements are influenced by their formulation, impacting safety and efficacy. The study will compare the PK properties of six different vitamin C formulations, each over a 24 h test period.
Detailed description
This is a randomized, 6-way crossover pharmacokinetic study to assess 6 different vitamin C formulations in healthy adults.
There is 1 comparator product (CP), 1 reference product (RP), and 4 test products (TP: TP1, TP2, TP3, TP4):
- TP1 (Vitamin C formulation 1, 1000 mg)
- TP2 (Vitamin C formulation 2, 1000 mg)
- TP3 (Vitamin C formulation 3, 1000 mg)
- TP4 (regular Vitamin C mega dose, 3000 mg)
- CP (Vitamin C formulation 4, 1000 mg)
- RP (regular Vitamin C, 1000 mg)
Each sequence will have 9 participants for a total of 27 participants.
- Sequence 1: TP1 → TP2 → TP3 → TP4 → CP → RP
- Sequence 2: RP → TP1 → TP2 → TP3 → TP4 → CP
- Sequence 3: CP → RP → TP1 → TP2 → TP3 → TP4
Pharmacokinetic blood sampling will occur pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 h post dose. Blood samples collected will be used to assess the PK profiles of all 6 formulations. PK parameters measured will include AUC0-24, Cmax, Tmax, AUCinf, T1/2, and Kel for L-ascorbic acid. L-ascorbic acid concentrations will be measured in urine to compare excretion during 0-4 h, 4-8 h, 8-10 h, and 10-24 h post-dose between all 6 formulations. L-ascorbic acid will also be measured in peripheral blood mononuclear cells at 8 h and 24 h post-dose to compare uptake and maintenance between all 6 formulations.
Gastrointestinal symptom questionnaire scores and total antioxidant capacity in plasma at 24 hours post-dose will also be compared between all 6 formulations.
Safety endpoints will be assessed throughout the study and will include reports of adverse events, vital signs, and safety laboratory assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TP1 → TP2 → TP3 → TP4 → CP → RP | Other | Dietary Supplement: TP1, Dietary Supplement: TP2, Dietary Supplement: TP3, Dietary Supplement: TP4, Dietary Supplement: CP, Dietary Supplement: RPEach test period will consist of 2 in-clinic visits to assess the pharmacokinetics of one of the assigned study products. On Day 1 of each test period participants will provide a pre-dose blood sample within 90-minutes before a dose of study product, followed by PK blood sample collections for the next 10 h. Participants will return to the clinic the following day for the 24 h PK blood sample collection. Each test period will be separated by a washout period. |
| RP → TP1 → TP2 → TP3 → TP4 → CP | Other | Dietary Supplement: TP1, Dietary Supplement: TP2, Dietary Supplement: TP3, Dietary Supplement: TP4, Dietary Supplement: CP, Dietary Supplement: RPEach test period will consist of 2 in-clinic visits to assess the pharmacokinetics of one of the assigned study products. On Day 1 of each test period participants will provide a pre-dose blood sample within 90-minutes before a dose of study product, followed by PK blood sample collections for the next 10 h. Participants will return to the clinic the following day for the 24 h PK blood sample collection. Each test period will be separated by a washout period. |
| CP → RP → TP1 → TP2 → TP3 → TP4 | Other | Dietary Supplement: TP1, Dietary Supplement: TP2, Dietary Supplement: TP3, Dietary Supplement: TP4, Dietary Supplement: CP, Dietary Supplement: RPEach test period will consist of 2 in-clinic visits to assess the pharmacokinetics of one of the assigned study products. On Day 1 of each test period participants will provide a pre-dose blood sample within 90-minutes before a dose of study product, followed by PK blood sample collections for the next 10 h. Participants will return to the clinic the following day for the 24 h PK blood sample collection. Each test period will be separated by a washout period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator.
- Are able to swallow the study products, in whole.
- Have a body mass index (BMI) between 18.0 to 29.9 kg/m2 (inclusive).
- Must have suitable veins for repeated venipuncture.
- No nicotine and/or nicotine products, including smoking or vaping of any kind (e.g., cigarettes) for at least 3 months before screening.
Key exclusion criteria (16 listed)
- Individuals who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- Have Type I diabetes, Type II diabetes, high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or thyroid disease.
- Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
- Have a history of heart disease, renal or hepatic impairment/disease, gout, hemochromatosis, glucose-6-phosphate dehydrogenase deficiency, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TP1Vitamin C formulation 1, 1000 mg | Dietary supplement | CP → RP → TP1 → TP2 → TP3 → TP4, RP → TP1 → TP2 → TP3 → TP4 → CP, TP1 → TP2 → TP3 → TP4 → CP → RP |
| TP2Vitamin C formulation 2, 1000 mg | Dietary supplement | CP → RP → TP1 → TP2 → TP3 → TP4, RP → TP1 → TP2 → TP3 → TP4 → CP, TP1 → TP2 → TP3 → TP4 → CP → RP |
| TP3Vitamin C formulation 3, 1000 mg | Dietary supplement | CP → RP → TP1 → TP2 → TP3 → TP4, RP → TP1 → TP2 → TP3 → TP4 → CP, TP1 → TP2 → TP3 → TP4 → CP → RP |
| TP4regular Vitamin C, 3000 mg | Dietary supplement | CP → RP → TP1 → TP2 → TP3 → TP4, RP → TP1 → TP2 → TP3 → TP4 → CP, TP1 → TP2 → TP3 → TP4 → CP → RP |
| CPVitamin C formulation 4, 1000 mg | Dietary supplement | CP → RP → TP1 → TP2 → TP3 → TP4, RP → TP1 → TP2 → TP3 → TP4 → CP, TP1 → TP2 → TP3 → TP4 → CP → RP |
| RPregular Vitamin C, 1000 mg | Dietary supplement | CP → RP → TP1 → TP2 → TP3 → TP4, RP → TP1 → TP2 → TP3 → TP4 → CP, TP1 → TP2 → TP3 → TP4 → CP → RP |
Primary outcome
Bioavailability of vitamin C compared between each of the liposomal formulations TP1 and TP2 to the traditional RP
Time frame: 0-24 hours
Area under the plasma concentration-time curve over 24 h (AUC0-24) for L-ascorbic acid following single dose administration of TP1 and TP2 and RP.
5 secondary outcomes
Pharmacokinetics (PK) of single doses of six vitamin C formulations
Time frame: 0-24 hours
Pharmacokinetics (PK) of single doses of six vitamin C formulations
Time frame: 0-24 hours
Bioavailability of vitamin C compared between six different formulations.
Time frame: 0-24 hours
Excretion of vitamin C in urine over a 24 h period compared between six different formulations.
Time frame: 0-24 hours
Uptake and maintenance of vitamin C in peripheral blood mononuclear cells (PBMCs) between six different formulations.
Time frame: 0-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TP1, TP2 and TP3 in people with Healthy and Pharmacokinetic, run by dsm-firmenich Switzerland AG at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of vitamin C compared between each of the liposomal formulations TP1 and TP2 to the traditional RP (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.