"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects (NCT02606773) | Clinical Trial Compass
CompletedPhase 1
"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects
Hungary32 participantsStarted 2015-06
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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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
What they're measuring
1
Plasma ascorbic acid concentration area under curve