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

Phase 1

Completed

• Conditions: Vitamin C Deficiency
• Interventions: Drug: Ascorbic Acid

• Registration Number: NCT02606773
• Lead Sponsor: Semmelweis University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-16
• Last Update Submitted: 2015-11-16
• Study First Posted: 2015-11-17
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
900 mg Novo C Plus	Ascorbic Acid	Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation)
500 mg oral vitamin C	Ascorbic Acid	Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export)
500 mg intravenous vitamin C	Ascorbic Acid	Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS)
600 mg Novo C plus	Ascorbic Acid	Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation)

Primary Outcome Measures

Name	Time	Method
Plasma ascorbic acid concentration area under curve	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 Outcome Measures

Name	Time	Method
Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0	24 hours
Urine ascorbic acid excretion	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).

Trial Locations

Locations (1)

Semmelweis University - 1st Departement of Internal Medicine; 🇭🇺 Budapest, Hungary