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

Vitamin C Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606773
• Other study ID #: NVP-14C
• Status: Completed
• Phase: Phase 1
• First received: November 13, 2015
• Last updated: November 16, 2015
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scientific and Medical Research Council Ethics Committee: Hungary
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascorbic Acid Deficiency
• Scurvy
• Vitamin C Deficiency

Intervention

Drug:
• Ascorbic Acid
Ascorbic acid in different ways and doses

Locations

Country	Name	City	State
Hungary	Semmelweis University - 1st Departement of Internal Medicine	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Semmelweis University	Novonex Pharma Kft

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	360 minutes	No
Secondary	Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0		24 hours	Yes
Secondary	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).	12 hours	No