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"Novo C Plus" Vitamin C Conta...

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

NCT ID: NCT02606773

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Vitamin C Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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600 mg Novo C plus

Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation)

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DRUG

Ascorbic acid in different ways and doses

900 mg Novo C Plus

Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation)

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DRUG

Ascorbic acid in different ways and doses

500 mg intravenous vitamin C

Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS)

Group Type ACTIVE_COMPARATOR

Ascorbic Acid

Intervention Type DRUG

Ascorbic acid in different ways and doses

500 mg oral vitamin C

Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export)

Group Type ACTIVE_COMPARATOR

Ascorbic Acid

Intervention Type DRUG

Ascorbic acid in different ways and doses

Interventions

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Ascorbic Acid

Ascorbic acid in different ways and doses

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novonex Pharma Kft

INDUSTRY

Sponsor Role collaborator

Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Istvan Takacs

Reader in university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Semmelweis University - 1st Departement of Internal Medicine

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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NVP-14C

Identifier Type: -

Identifier Source: org_study_id