Back to results"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects
Primary Purpose
Vitamin C Deficiency
Status
Completed
Phase
Phase 1
Locations
Hungary
Study Type
Interventional
Intervention
Ascorbic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin C Deficiency focused on measuring vitamin C supplementation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Semmelweis University - 1st Departement of Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
600 mg Novo C plus
900 mg Novo C Plus
500 mg intravenous vitamin C
500 mg oral vitamin C
Arm Description
Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation)
Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation)
Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS)
Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0
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).
Full Information
NCT ID
NCT02606773
First Posted
November 13, 2015
Last Updated
November 16, 2015
Sponsor
Semmelweis University
Collaborators
Novonex Pharma Kft
1. Study Identification
Unique Protocol Identification Number
NCT02606773
Brief Title
"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects
Official Title
Open-label, Randomized Comparator Study for Evaluation the Bioavailability of "Novo C Plus" Vitamin C Containing Dietary Supplement in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University
Collaborators
Novonex Pharma Kft
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin C Deficiency
Keywords
vitamin C supplementation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
600 mg Novo C plus
Arm Type
Experimental
Arm Description
Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation)
Arm Title
900 mg Novo C Plus
Arm Type
Experimental
Arm Description
Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation)
Arm Title
500 mg intravenous vitamin C
Arm Type
Active Comparator
Arm Description
Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS)
Arm Title
500 mg oral vitamin C
Arm Type
Active Comparator
Arm Description
Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export)
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Intervention Description
Ascorbic acid in different ways and doses
Primary Outcome Measure Information:
Title
Plasma ascorbic acid concentration area under curve
Description
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.
Time Frame
360 minutes
Secondary Outcome Measure Information:
Title
Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
24 hours
Title
Urine ascorbic acid excretion
Description
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).
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
Semmelweis University - 1st Departement of Internal Medicine
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects
We'll reach out to this number within 24 hrs