VITATOPS: A Study of VITAmins TO Prevent Stroke

September 7, 2020 updated by: VITATOPS

VITATOPS - A Study of VITAmins TO Prevent Stroke

The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B12 and vitamin B6, it is not known whether lowering tHcy, by means of multivitamin therapy, can prevent stroke and other major atherothromboembolic vascular events, dementia and depression.

Purpose: To determine whether vitamin supplements (folic acid 2 mg, B6 25 mg, B12 500 ug) reduce the risk of stroke, other serious vascular events, dementia and depression in patients with recent stroke or transient ischemic attacks of the brain or eye (TIA).

Methods: An international, multi-center, randomized, double-blind, placebo-controlled clinical trial.

Subjects: Patients with stroke or TIA in the previous 7 months.

Primary outcome measure: Non-fatal stroke, non-fatal myocardial infarction, or death due to vascular causes.

Secondary outcome measures: TIA, Revascularisation procedures, Dementia, Depression.

Sample size calculation: To reliably identify a 15% reduction in relative risk of the primary outcome event from 8% to 6.8% per year with an alpha of 0.05 and power of 80%, 8,000 patients need to be randomized and followed-up for an average of two years.

Current progress: As of November, 2004, more than 4,400 patients have been randomized in 73 centers in 19 countries in five continents: Australia, Austria, Belgium, Brazil, Hong Kong, Italy, Malaysia, Moldova, Netherlands, New Zealand, Pakistan, Philippines, Portugal, Republic of Georgia, Serbia & Monte Negro, Singapore, Sri Lanka, United Kingdom, and United States.

VITATOPS aims to recruit and follow up 8,000 patients between 2000 and 2006, and provide a reliable estimate of the safety and effectiveness of dietary supplementation with folic acid, vitamin B12, and vitamin B6 in reducing recurrent serious vascular events, dementia and depression among a wide range of patients with stroke and TIA.

Study Type

Interventional

Enrollment (Actual)

8164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Gosford, Australia
        • Central Coast Neuroscience Research
      • New South Wales, Australia
        • John Hunter Hospital
      • New South Wales, Australia
        • Bankstown Hospital
      • New South Wales, Australia
        • Liverpool Hospital
      • Perth, Australia
        • Royal Perth Hospital
      • Queensland, Australia
        • Greenslopes Hospital
      • Queensland, Australia
        • Nambour Hospital
      • South Australia, Australia
        • Flinders & Griffiths
      • Tasmania, Australia
        • Royal Hobart Hospital
      • Victoria, Australia
        • Alfred Hospital
      • Victoria, Australia
        • Beleura & Frankston Hospital
      • Victoria, Australia
        • Box Hill Hospital
      • Victoria, Australia
        • National Stroke Research Institute - Austin Health
      • Western Australia, Australia
        • Fremantle Hospital
      • Western Australia, Australia
        • Joondalup Hospital
      • Western Australia, Australia
        • Sir Charles Gairdner Hospital
  • Austria
      • Graz, Austria
        • Karl-Franzens University Graz
  • Belgium
      • Brugge, Belgium
        • Algemeen Ziekenhuis Sint-Jan Autonome Verzorgingsinstelling
  • Brazil
      • Rio de Janeiro, Brazil
        • Universidade Federal Fluminense & Universidade Federal do Rio de Janeiro
  • Georgia
      • Tbilisi, Georgia
        • Sarajishvili Institute of Neurology and Neurosurgery
  • Hong Kong
      • Pokfulam, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hospital
  • India
      • Annamalainagar, India
        • Rajah Muthaiah Medical College
      • Bangalore, India
        • St John's Medical College Hospital
      • Bikaner, India
        • SP Medical College
      • Calicut, India
        • Baby Memorial Hospital
      • Chennai, India
        • KS Hospital
      • Cochin, India
        • Amrita Institute of Medical Science
      • Hyderabad, India
        • Mediciti Hospital
      • Hyderabad, India
        • Care Hopstial
      • Hyderabad, India
        • Mahaveer Hospital & Research Centre
      • Indore, India
        • MGM Medical College & MY Hospital
      • Jaipur, India
        • Monilek Hospital
      • Kolkata, India
        • Centauri, The Albert Road Clinic
      • Lucknow, India
        • CSMMU
      • Ludhiana, India
        • Christian Medical College & Hospital
      • New Delhi, India
        • Sir Ganga Ram Hospital
      • New Delhi, India
        • G.B. Pant Hospital
      • Patiaala, India
        • Sadhbavana Medical & Heart Institute
      • Perambur, India
        • Railway Hospital
      • Pune, India
        • Ruby Hall Clinic
      • Pune, India
        • Poona Hospital
      • Trichy, India
        • NeuroCenter
      • Visakhapatnam, India
        • Care Hospital
      • Wardha, India
        • Mahatma Gandhi Institute
  • Italy
      • Brescia, Italy
        • Spedali Civili di Brescia
      • Busto Arsizio, Italy
        • Ospedale di Circolo de Busto Arsizio
      • Macerata, Italy
        • Ospedale di Macerata
      • Pavia, Italy
        • IRCCS Fondazione Istituto Neurologico C Mondino
      • Perugia, Italy
        • University Of Perugia
      • Perugia, Italy
        • Perugia Stroke Service & Citta Della Peive
      • Vittoria, Italy
        • Ospedale R Guzzardi
  • Malaysia
      • Kelantan, Malaysia
        • Hospital Universiti Sains Malaysia
      • Kuala Lumpur, Malaysia
        • University of Malaya Medical Centre
  • Moldova, Republic of
      • Chishinau, Moldova, Republic of
        • City Emergency Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Slotervaartziekenhuis
      • Goes, Netherlands
        • Oosterscheldeziekenhuis
      • Utrecht, Netherlands
        • University Medical Center Utrecht
  • New Zealand
      • Auckland, New Zealand
        • Auckland Hospital
      • Hastings, New Zealand
        • Hawkes Bay Hospital
      • Palmerston North, New Zealand
        • Palmerston North Hospital
      • Takapuna, New Zealand
        • North Shore Hospital
      • Wellington South, New Zealand
        • Wellington Hospital
  • Pakistan
      • Islamabad, Pakistan
        • KRL University
      • Islamabad, Pakistan
        • Pakistan Institute of Medical Sciences
      • Karachi, Pakistan
        • DUHS - Civil Hospital
      • Karachi, Pakistan
        • DUHS - Jinnah Hospital
      • Wah Cantt, Pakistan
        • POF Hospital Wah Cantt.
  • Philippines
      • Cebu City, Philippines
        • Chong Hua Hospital
      • Cebu City, Philippines
        • Cagayan de Oro Medical Center
      • Cebu City, Philippines
        • Cebu Doctor's Hospital
      • Cebu City, Philippines
        • Cebu Velez General Hospital/ Visayas Comm. Medical Center
      • Cebu City, Philippines
        • Vicente Sotto Memorial Hospital
      • East Santiago City, Philippines
        • Cagayan Valley Medical Center
      • Manila, Philippines
        • Jose R Reyes Memorial Medical Centre
      • Manila, Philippines
        • University Santo Tomas Hospital
  • Portugal
      • Estarreja, Portugal
        • Hospital Visconde de Salreu
      • Lisboa, Portugal
        • Hospital de Santa Maria
      • Oliveira de Azemeis, Portugal
        • Hospital Distrital de Oliverira de Azemeis
      • Porto, Portugal
        • Hospital Geral de Santo Antonio
  • Serbia
      • Novisad, Serbia
        • University of Novi Sad - Neurology & Neurosurgery
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
  • Sri Lanka
      • Colombo, Sri Lanka
        • National Hospital of Sri Lanka
      • Ragama, Sri Lanka
        • University of Kelaniya
  • United Kingdom
      • Aberdeen, United Kingdom
        • Aberdeen Royal Infirmary
      • Barking, United Kingdom
        • Redbridge Health Care
      • Barnsley, United Kingdom
        • Barnsley District Hospital
      • Belfast, United Kingdom
        • The Royal Victoria Hospital
      • Ceredigion, United Kingdom
        • Bronglais General Hospital
      • Edinburgh, United Kingdom
        • Western General Hospital, Edinburgh
      • Exeter, United Kingdom
        • Royal Devon & Exeter Hospital
      • Glasgow, United Kingdom
        • Western Infirmary
      • Huddersfield, United Kingdom
        • St Luke's Hospital
      • Kent, United Kingdom
        • William Harvey Hospital
      • Liverpool, United Kingdom
        • University Hospital Aintree
      • Londonderry, United Kingdom
        • Altnagelvin Hospital
      • Luton, United Kingdom
        • Luton and Dunstable Hospital
      • Newcastle, United Kingdom
        • Royal Victoria Infirmary, Newcastle
      • North Shields, United Kingdom
        • North Tyneside District General Hospital
      • Nottingham, United Kingdom
        • Nottingham City Hospital
      • Paddington, United Kingdom
        • St Mary's Paddington Hospital
      • Rotherham, United Kingdom
        • Rotherham General Hospital
      • Stirling, United Kingdom
        • Stirling Royal Infirmary
      • Stockport, United Kingdom
        • Stepping Hill Hospital
      • Taunton, United Kingdom
        • Musgrove Park Hosptial
      • Torquay, United Kingdom
        • Torbay Hospital
    • Shaffordshire
      • Stoke on Trent, Shaffordshire, United Kingdom
        • University Hospital of North Staffordshire
  • United States
    • New York
      • New York, New York, United States
        • JFK Hospital / Seton Hall University
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • Abington Memorial Hospital
    • South Carolina
      • Columbia, South Carolina, United States
        • South Carolina VA Hospital
      • Columbia, South Carolina, United States
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting within seven months of stroke (ischemic or hemorrhagic) or TIA
  • Agree to take study medication
  • Be geographically accessible for follow-up
  • Provide written informed consent

Exclusion Criteria:

  • Taking folic acid or B6 on medical advice
  • Use of vitamin supplements containing folate, B6 or B12 (unless patient agrees to take study medication instead of the vitamin supplements which they usually take)
  • Taking Methotrexate for any reason
  • Pregnancy or women of child-bearing potential who are at risk of pregnancy
  • Limited life expectancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug)
Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.
Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo
multivitamin
Other Names:
  • VITATOPS study tablet
Placebo Comparator: Placebo Tablet
Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes
Time Frame: The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).
The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VITATOPS

Collaborators

National Health and Medical Research Council, Australia
National Heart Foundation, Australia
Medical Health Research Infrastructure Council, Australia

Investigators

  • Principal Investigator: Graeme Hankey, MBBS/MD, Royal Perth Hospital / University of Western Australia
  • Study Director: Ross Baker, MBBS/BMedSc, Royal Perth Hospital
  • Study Director: John Eikelboom, MBBS/FRACP, Royal Perth Hospital
  • Study Director: Konrad Jamrozik, MBBS, The University of Queensland
  • Study Director: Frank van Bockxmeer, BSc/PhD, Royal Perth Hospital
  • Study Director: Siobhan Hickling, BSc/MPH, The University of Western Australia
  • Study Director: Anna Gelavis, BPharm, Royal Perth Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 24, 2004

First Submitted That Met QC Criteria

November 24, 2004

First Posted (Estimate)

November 25, 2004

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ec550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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