NCT03148236

Brief Summary

Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered every six hours with a 30 minute IV infusion time per dose, compared to matched placebo infusion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

May 1, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 18, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

May 1, 2017

Results QC Date

February 22, 2019

Last Update Submit

March 28, 2019

Conditions

Atrial Fibrillation Ablation

Outcome Measures

Primary Outcomes (10)

  • Change in Creatinine Levels

    Change in Kidney Function

    Baseline to 24 hours

  • Change in Plasma Levels of Ascorbic Acid

    Change in plasma levels of ascorbic acid

    baseline to 24 hours

  • Change in hsCRP

    Biomarker of inflammation

    baseline to 24 hours

  • Change in Interleukin (IL-6)

    Biomarker of inflammation

    baseline to 24 hours

  • Change in Von Willebrand Factor (vWF)

    Biomarker of blood vessel damage

    baseline to 24 hours

  • Change in Creatinine Levels

    Change in kidney function

    Baseline to 30 days

  • Change in Plasma Ascorbic Acid Level

    Change in plasma ascorbic acid level

    Baseline to 30 days

  • Change in hsCRP

    Biomarker of inflammation

    baseline to 30 days

  • Change in Interleukin (IL-6)

    Biomarker of inflammation

    baseline to 30 days

  • Change in Von Willebrand Factor (vWF)

    Biomarker of blood vessel damage

    baseline to 30 days

Secondary Outcomes (1)

  • Post Procedural Pain

    baseline to 24 hours

Study Arms (2)

Vitamin C

ACTIVE COMPARATOR
Drug: Vitamin C

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Vitamin CDRUG

200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W

Also known as: Ascorbic Acid
Vitamin C
PlaceboOTHER

50mL infused over 30 minutes

Also known as: D5W
Placebo

Eligibility Criteria

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

You may qualify if:

  • Age \>/= 21 years
  • Diagnosis of atrial fibrillation with plans for a catheter-based ablation procedure
  • Ability to provide informed consent and willingness to be included in the study

You may not qualify if:

  • Known allergy to Vitamin C
  • Inability to obtain informed consent
  • Diabetes mellitus either requiring the use of insulin therapy or not requiring the use of insulin therapy but which is uncontrolled, defined as a glycosylated hemoglobin of greater than or equal to 8%
  • Prior catheter-based ablation for atrial fibrillation
  • Pregnancy or breast feeding
  • Active renal calculus
  • Active acute or chronic infection (including HIV or hepatitis C)
  • Active or recent (within 5 years) malignancy
  • Autoimmune or autoinflammatory disease
  • Recent or active use of immunosuppressive medications
  • Non-English speaking
  • Ward of the state (inmate, other)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Trankle CR, Puckett L, Swift-Scanlan T, DeWilde C, Priday A, Sculthorpe R, Ellenbogen KA, Fowler A, Koneru JN. Vitamin C Intravenous Treatment In the Setting of Atrial Fibrillation Ablation: Results From the Randomized, Double-Blinded, Placebo-Controlled CITRIS-AF Pilot Study. J Am Heart Assoc. 2020 Feb 4;9(3):e014213. doi: 10.1161/JAHA.119.014213. Epub 2020 Jan 30.

    PMID: 32013700DERIVED

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Results Point of Contact

Title
Cory Trankle, MD
Organization
Virginia Commonwealth University
cory.trankle@vcuhealth.org
804-213-2679

Study Officials

  • Jayanthe Koneru, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 10, 2017

Study Start

September 18, 2017

Primary Completion

March 13, 2018

Study Completion

March 13, 2018

Last Updated

April 16, 2019

Results First Posted

April 16, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)