Vitamin C DeficiencyNCT04886752
The Effect of Liposome Vitamin C on the Absorption and Metabolism of the Human Body.
A study testing vitamin C without liposome, liposomal process A vitamin C and liposomal process B vitamin C (Double Nutri™) in people with Vitamin C Deficiency, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To evaluate the difference between vitamin C in the form of oral liposomes and general vitamin C in a fixed period of time in plasma and urine. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin C Deficiency
- What is being tested?
- vitamin C without liposome, liposomal process A vitamin C and liposomal process B vitamin C (Double Nutri™)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jun 2019to 31 Dec 2020
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between 20-60 years old,
- No heart, liver, kidney, endocrine and major organic diseases
Who cannot join
- Renal insufficiency and dialysis
- Cancer
- Underweight (BMI≦17) or obese (BMI≧27),
- Take chronic disease drugs,
- Blood pressure systolic blood pressure ≧130 mmHg or diastolic blood pressure ≧85 mmHg,
- Too high fasting blood glucose ≧ 100 mg/dL,
Show all 13Show fewer
- Triglyceride ≧ 150 mg/dL,Total cholesterol ≧ 200 mg/dL,
- Have a history of vitamin C allergy,
- People with mental illness,
- Pregnant or breastfeeding women,
- Hematosis,
- Kidney stones,
- Long-term vitamin C supplements (at least 200 mg per day for more than one month)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Liposome Vitamin C on the Absorption
To evaluate the difference between vitamin C in the form of oral liposomes and general vitamin C in a fixed period of time in plasma and urine.
Read the detailed description
we recruited 11 healthy subjects and adopted a cross-over test. the subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start. The subjects were informed to consume one sachet vitamin C without liposome, liposomal process A vitamin C, or liposomal process B vitamin C (Double Nutri™) every test, and vitamin C concentration was measured at baseline (0 hours), 0.5, 1, 2, 3, 4, and 8 hours after taking test sample.
- Conditions
- Vitamin C Deficiency
- Being tested
- vitamin C without liposome, liposomal process A vitamin C, liposomal process B vitamin C (Double Nutri™)
- Medical subject headings
- Ascorbic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin C without liposomeDietary supplement
subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start
liposomal process A vitamin CDietary supplement
subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start
liposomal process B vitamin C (Double Nutri™)Dietary supplement
subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start
| Study group | Role | What they receive |
|---|---|---|
| vitamin C without liposome | Sham comparator | vitamin C without liposome Receives: Dietary Supplement: vitamin C without liposome |
| liposomal process A vitamin C | Placebo comparator | liposomal process A vitamin C Receives: Dietary Supplement: liposomal process A vitamin C |
| liposomal process B vitamin C (Double Nutri™) | Experimental | liposomal process B vitamin C (Double Nutri™) Receives: Dietary Supplement: liposomal process B vitamin C (Double Nutri™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin c detection
vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II
Measured: at 8 hours after taking test sample
The change of Triglyceride
Venous blood was sampled to measure concentrations of Triglyceride
Measured: at 8 hours after taking test sample
The change of body mass index (BMI)
BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.
Measured: Time 0, 0.5, 1, 2, 3, 4, and 8 hours after taking test sample
The change of aspartate aminotransferase
Venous blood was sampled to measure concentrations of aspartate aminotransferase
Measured: at 8 hours after taking test sample
The change of alanine aminotransferase
Venous blood was sampled to measure concentrations of alanine aminotransferase
Measured: at 8 hours after taking test sample
The change of creatine
Venous blood was sampled to measure concentrations of creatine
Measured: at 8 hours after taking test sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start10 Jun 2019
- Primary completion9 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin C DeficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaw-Shiun Tsai, Doctor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886752
- Sponsor's protocol ID
- 201903113RSA
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 14 May 2021
- 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 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liposome Vitamin C on the Absorption
- ClinicalTrials.gov ID
- NCT04886752
- Acronym / sponsor ID
- 201903113RSA
- Conditions
- Vitamin C Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 May 2021 (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.
To evaluate the difference between vitamin C in the form of oral liposomes and general vitamin C in a fixed period of time in plasma and urine.
Detailed description
we recruited 11 healthy subjects and adopted a cross-over test. the subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start. The subjects were informed to consume one sachet vitamin C without liposome, liposomal process A vitamin C, or liposomal process B vitamin C (Double Nutri™) every test, and vitamin C concentration was measured at baseline (0 hours), 0.5, 1, 2, 3, 4, and 8 hours after taking test sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vitamin C without liposome | Sham comparator | Dietary Supplement: vitamin C without liposomevitamin C without liposome |
| liposomal process A vitamin C | Placebo comparator | Dietary Supplement: liposomal process A vitamin Cliposomal process A vitamin C |
| liposomal process B vitamin C (Double Nutri™) | Experimental | Dietary Supplement: liposomal process B vitamin C (Double Nutri™)liposomal process B vitamin C (Double Nutri™) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults between 20-60 years old,
- No heart, liver, kidney, endocrine and major organic diseases
Key exclusion criteria (13 listed)
- Renal insufficiency and dialysis
- Cancer
- Underweight (BMI≦17) or obese (BMI≧27),
- Take chronic disease drugs,
- Blood pressure systolic blood pressure ≧130 mmHg or diastolic blood pressure ≧85 mmHg,
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 |
|---|---|---|
| vitamin C without liposomesubjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start | Dietary supplement | vitamin C without liposome |
| liposomal process A vitamin Csubjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start | Dietary supplement | liposomal process A vitamin C |
| liposomal process B vitamin C (Double Nutri™)subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start | Dietary supplement | liposomal process B vitamin C (Double Nutri™) |
Primary outcome
vitamin c detection
Time frame: at 8 hours after taking test sample
vitamin c was assessed by Ascorbic Acid Colorimetric Assay Kit II
The change of Triglyceride
Time frame: at 8 hours after taking test sample
Venous blood was sampled to measure concentrations of Triglyceride
The change of body mass index (BMI)
Time frame: Time 0, 0.5, 1, 2, 3, 4, and 8 hours after taking test sample
BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.
The change of aspartate aminotransferase
Time frame: at 8 hours after taking test sample
Venous blood was sampled to measure concentrations of aspartate aminotransferase
The change of alanine aminotransferase
Time frame: at 8 hours after taking test sample
Venous blood was sampled to measure concentrations of alanine aminotransferase
The change of creatine
Time frame: at 8 hours after taking test sample
Venous blood was sampled to measure concentrations of creatine
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 14 May 2021.
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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.
Jaw-Shiun Tsai, Doctor principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin C without liposome, liposomal process A vitamin C and liposomal process B vitamin C (Double Nutri™) in people with Vitamin C Deficiency, run by TCI Co., Ltd. at 1 site in Taiwan.
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 2 inclusion and 13 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 14 May 2021. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
vitamin c detection (time frame: at 8 hours after taking test sample). The study lists 6 primary outcomes in all. 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 14 May 2021.