NCT00519337

Brief Summary

The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce inflammation following heart surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2008

Typical duration for phase_4

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

August 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

August 20, 2007

Last Update Submit

January 3, 2012

Conditions

Cardiac SurgeryInflammation

Keywords

Atrial Fibrillationcardiac surgeryascorbic acidvitamin-cinflammation

Outcome Measures

Primary Outcomes (1)

  • In CTS patients receiving standard of care therapy,evaluate the effect of ascorbic acid therapy on c-reactive protein (CRP) concentration on post-CTS day 3 and the total post-CTS systemic exposure to CRP over 4 days.

    4 Postoperative Days

Secondary Outcomes (1)

  • Evaluate the effect of high intensity versus low intensity statin therapy on blood concentrations of fibrinogen, and White blood cell count on post-CTS days 3 and the total post-CTS systemic exposure to these biomarkers over 4 days.

    4 Postoperative Days

Study Arms (2)

1

ACTIVE COMPARATOR

Ascorbic acid

Drug: Ascorbic acid

2

PLACEBO COMPARATOR

Identical placebo

Drug: Placebo

Interventions

Ascorbic acidDRUG

Ascorbic acid, 2 g p.o. the night before surgery followed by 500mg B.I.D. for 4 post-operative days

Also known as: Vitamin-C
1
PlaceboDRUG

Placebo capsule, 4 capsules the night before surgery followed by 1 capsule B.I.D. for 4 postoperative days

Also known as: Identical Placebo
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiothoracic surgery

You may not qualify if:

  • Pregnancy
  • Prior hypersensitivity to ascorbic acid
  • Renal Calculi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hosptial

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

InflammationAtrial Fibrillation

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • C. Michael White, Pharm.D.

    Hartford Hospital, University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 22, 2007

Study Start

October 1, 2008

Primary Completion

October 1, 2009

Study Completion

April 1, 2011

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

US(1)