NCT02606773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

November 13, 2015

Last Update Submit

November 16, 2015

Conditions

Vitamin C Deficiency

Keywords

vitamin C supplementation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

Study Arms (4)

600 mg Novo C plus

EXPERIMENTAL

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

Drug: Ascorbic Acid

900 mg Novo C Plus

EXPERIMENTAL

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

Drug: Ascorbic Acid

500 mg intravenous vitamin C

ACTIVE COMPARATOR

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

Drug: Ascorbic Acid

500 mg oral vitamin C

ACTIVE COMPARATOR

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

Drug: Ascorbic Acid

Interventions

Ascorbic AcidDRUG

Ascorbic acid in different ways and doses

500 mg intravenous vitamin C500 mg oral vitamin C600 mg Novo C plus900 mg Novo C Plus

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University - 1st Departement of Internal Medicine

Budapest, 1083, Hungary

Location

MeSH Terms

Conditions

Ascorbic Acid Deficiency

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in university

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 17, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

HU(1)