Vitamin C DeficiencyPhase 1NCT02606773
"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects
A Phase 1 study testing Ascorbic Acid in people with Vitamin C Deficiency, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of this study is to evaluate the bioavailability of "Novo C Plus" vitamin C containing dietary supplement compared to licensed vitamin C medications. The novelty of this product is the liposomal formulation. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin C Deficiency
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteHungary
- Study dates
- Jun 2015to Sep 2015
- Phase
- Phase 1
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21-65 years old healthy volunteers
- body weight >45 kg
- body height >150 cm
- plasma ascorbic acid at screening <75 µmol/l
- signed written informed consent
- subject agrees avoid vitamin C containing medications and dietary supplements from screening until V0 visit (maximum 15 days)
- subject agrees to avoid high activity physical exercise 72 hours prior to V0 visit
Who cannot join
- confirmed or suspected active infection
- liver or renal failure (equal or greater than CKD3)
- chronic disease that affects absorption or vitamin C metabolism
- severe metabolic disorder
- body mass index >35 kg/m2
- malabsorption syndrome that affects vitamin C metabolism
Show all 18Show fewer
- heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with >100/min ventricular rate
- gastrointestinal bleeding in past three months
- uncontrolled diabetes mellitus (HbA1c>8,5%)
- malignant disease
- alcohol or drug abuse
- active psychiatric disorder, intention for suicidal, disorders with unconsciousness
- psychopathic disorder, lack of cooperation
- known coagulopathy
- chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
- untreated hypertension if blood pressure is greater than 165/95 mmHg
- gravidity or breastfeeding
- taking more than 100 mg vitamin C daily within 2 weeks to screening
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University - 1st Departement of Internal Medicine
Budapest, 1083
About this study
Official title: Open-label, Randomized Comparator Study for Evaluation the Bioavailability of "Novo C Plus" Vitamin C Containing Dietary Supplement in Healthy Subjects
The aim of this study is to evaluate the bioavailability of "Novo C Plus" vitamin C containing dietary supplement compared to licensed vitamin C medications. The novelty of this product is the liposomal formulation.
- Conditions
- Vitamin C Deficiency
- Being tested
- Ascorbic Acid
- Keywords
- vitamin C supplementation
- 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.
Ascorbic AcidDrug
Ascorbic acid in different ways and doses
| Study group | Role | What they receive |
|---|---|---|
| 600 mg Novo C plus | Experimental | Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation) Receives: Drug: Ascorbic Acid |
| 900 mg Novo C Plus | Experimental | Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation) Receives: Drug: Ascorbic Acid |
| 500 mg intravenous vitamin C | Active comparator | Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS) Receives: Drug: Ascorbic Acid |
| 500 mg oral vitamin C | Active comparator | Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export) Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma ascorbic acid concentration area under curve
Plasma ascorbic acid concentration will be measured from peripheral blood samples after 30-45-60-90-120-180-240-300-360 minutes after getting the medication. Area under curve of time - plasma concentration curve will be calculated.
Measured: 360 minutes
Secondary outcomes (2)
Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 24 hours
Urine ascorbic acid excretion
Urine is collected for 12 hours after taking study drug, and urine ascorbic acid excretion will be calculated: urine ascorbic acod concentration (uM)×collected urine (L).
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
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.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Novonex Pharma Kft
- Responsible party
- Principal investigator, Istvan Takacs, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606773
- Sponsor's protocol ID
- NVP-14C
- Status last verified
- Nov 2015
- First submitted
- 13 Nov 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized Comparator Study for Evaluation the Bioavailability of "Novo C Plus" Vitamin C Containing Dietary Supplement in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02606773
- Acronym / sponsor ID
- NVP-14C
- Conditions
- Vitamin C Deficiency
- Keywords
- vitamin C supplementation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Novonex Pharma Kft
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Nov 2015 (estimated)
- 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.
The aim of this study is to evaluate the bioavailability of "Novo C Plus" vitamin C containing dietary supplement compared to licensed vitamin C medications. The novelty of this product is the liposomal formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 600 mg Novo C plus | Experimental | Drug: Ascorbic AcidSingle dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation) |
| 900 mg Novo C Plus | Experimental | Drug: Ascorbic AcidSingle dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation) |
| 500 mg intravenous vitamin C | Active comparator | Drug: Ascorbic AcidSingle dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS) |
| 500 mg oral vitamin C | Active comparator | Drug: Ascorbic AcidSingle dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 21-65 years old healthy volunteers
- body weight >45 kg
- body height >150 cm
- plasma ascorbic acid at screening <75 µmol/l
- signed written informed consent
Key exclusion criteria (18 listed)
- confirmed or suspected active infection
- liver or renal failure (equal or greater than CKD3)
- chronic disease that affects absorption or vitamin C metabolism
- severe metabolic disorder
- body mass index >35 kg/m2
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 |
|---|---|---|
| Ascorbic AcidAscorbic acid in different ways and doses | Drug | 500 mg intravenous vitamin C, 500 mg oral vitamin C, 600 mg Novo C plus, 900 mg Novo C Plus |
Primary outcome
Plasma ascorbic acid concentration area under curve
Time frame: 360 minutes
Plasma ascorbic acid concentration will be measured from peripheral blood samples after 30-45-60-90-120-180-240-300-360 minutes after getting the medication. Area under curve of time - plasma concentration curve will be calculated.
2 secondary outcomes
Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 hours
Urine ascorbic acid excretion
Time frame: 12 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 17 Nov 2015.
Related trials for Vitamin C Deficiency
RecruitingObservational study
A Long-term Observational Study to Describe the Use of Vitamin-C Injektopas® 7.5 g in Patients With Vitamin C Deficiency
Deficiency, Vitamin C, Chronic Disease
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Not yet recruiting
Link Between ASCorbemia Level and Osteoporosis
Osteoporosis, Vitamin C Deficiency
Recruiting
The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
Anemia, Iron Deficiency Anemia
Not yet recruitingPhase 1
High-Dose Vitamin C in G6PDA and Pyruvate Kinase Deficiency: A Safety Study
Pyruvate Kinase Deficiency, Glucose 6 Phosphate Dehydrogenase Deficiency
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 Phase 1 study testing Ascorbic Acid in people with Vitamin C Deficiency, run by Semmelweis University at 1 site in Hungary.
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 7 inclusion and 18 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 17 Nov 2015. 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 Hungary. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma ascorbic acid concentration area under curve (time frame: 360 minutes). 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 17 Nov 2015.