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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02606773

Enrollment

Registered

2015-11-17

Start date

2015-06-30

Completion date

2015-09-30

Last updated

2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin C Deficiency

Keywords

vitamin C supplementation

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.

Interventions

DRUGAscorbic Acid

Ascorbic acid in different ways and doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026