Vitamin C in Atrial Fibrillation Ablation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2018-03-13

Brief Summary

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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

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Detailed Description

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Conditions

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Atrial Fibrillation Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin C

Group Type ACTIVE_COMPARATOR

Vitamin C

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

50mL infused over 30 minutes

Interventions

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Vitamin C

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

Intervention Type DRUG

Placebo

50mL infused over 30 minutes

Intervention Type OTHER

Other Intervention Names

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Ascorbic Acid D5W

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Known allergy to Vitamin C
2. Inability to obtain informed consent
3. 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%
4. Prior catheter-based ablation for atrial fibrillation
5. Pregnancy or breast feeding
6. Active renal calculus
7. Active acute or chronic infection (including HIV or hepatitis C)
8. Active or recent (within 5 years) malignancy
9. Autoimmune or autoinflammatory disease
10. Recent or active use of immunosuppressive medications
11. Non-English speaking
12. Ward of the state (inmate, other)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No