"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects

November 16, 2015 updated by: Istvan Takacs, Semmelweis University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis University - 1st Departement of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 600 mg Novo C plus
Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation)
Drug: Ascorbic Acid
Ascorbic acid in different ways and doses
Experimental: 900 mg Novo C Plus
Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation)
Drug: Ascorbic Acid
Ascorbic acid in different ways and doses
Active Comparator: 500 mg intravenous vitamin C
Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS)
Drug: Ascorbic Acid
Ascorbic acid in different ways and doses
Active Comparator: 500 mg oral vitamin C
Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export)
Drug: Ascorbic Acid
Ascorbic acid in different ways and doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
360 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 24 hours
24 hours
Urine ascorbic acid excretion
Time Frame: 12 hours
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).
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Collaborators

Novonex Pharma Kft

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVP-14C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin C Deficiency

Clinical Trials on Ascorbic Acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe