Skip to main content
OpenTrials
Completed

NCT Number: NCT02606773

"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Semmelweis University - 1st Departement of Internal Medicine

Budapest, 1083, Hungary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ascorbic acid

Drug

Ascorbic acid in different ways and doses

Primary outcomes

  1. 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.

Secondary outcomes

  1. Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 24 hours

  2. 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).

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Collaborators

  • Novonex Pharma Kft

Registry information

Official study title

Open-label, Randomized Comparator Study for Evaluation the Bioavailability of "Novo C Plus" Vitamin C Containing Dietary Supplement in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2015
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.