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VITATOPS: A Study of VITAmins TO Prevent Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00097669
Recruitment Status : Completed
First Posted : November 25, 2004
Results First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
National Heart Foundation, Australia
Medical Health Research Infrastructure Council, Australia
Information provided by (Responsible Party):
VITATOPS

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Stroke
Transient Ischemic Attack
Interventions Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo
Other: Placebo
Enrollment 8164
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) Placebo Tablet
Hide Arm/Group Description

Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.

Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin

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.
Period Title: Overall Study
Started 4089 4075
Completed 4089 4075
Not Completed 0 0
Arm/Group Title Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) Placebo Tablet Total
Hide Arm/Group Description

Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.

Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin

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. Total of all reporting groups
Overall Number of Baseline Participants 4089 4075 8164
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4089 participants 4075 participants 8164 participants
62.5  (12.6) 62.6  (12.4) 62.6  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4089 participants 4075 participants 8164 participants
Female
1475
  36.1%
1471
  36.1%
2946
  36.1%
Male
2614
  63.9%
2604
  63.9%
5218
  63.9%
Functional severity of qualifying stroke   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4089 participants 4075 participants 8164 participants
Independent (Oxford handicap score 0-3) 3035 3024 6059
Dependent (Oxford handicap score 3,4 or 5) 951 943 1894
[1]
Measure Description: Oxford Handicap Score (<3 = functionally independent; 3-5= functional dependent on help)
past history of stroke, prior to qualifying stroke or transient ischemic attack (TIA)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4089 participants 4075 participants 8164 participants
624 658 1282
[1]
Measure Description: This measure refers to the number of randomised patients who had a history of a previous stroke, prior to the stroke or transient ischemic attack (TIA) that qualified them for entry into the trial.
laboratory results for fasting homocysteine   [1] 
Mean (Standard Deviation)
Unit of measure:  Micromoles per liter
Number Analyzed 4089 participants 4075 participants 8164 participants
14.4  (9.2) 14.2  (7.7) 14.3  (8.5)
[1]
Measure Description: Fasting blood homocysteine concentrations were measured and expressed in micromoles per litre
1.Primary Outcome
Title Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes
Hide Description [Not Specified]
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).
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis population of all patients randomised (n=8164)
Arm/Group Title Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) Placebo Tablet
Hide Arm/Group Description:

Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.

Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin

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.
Overall Number of Participants Analyzed 4089 4075
Measure Type: Count of Participants
Unit of Measure: Participants
616
  15.1%
678
  16.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug), Placebo Tablet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments

We used Kaplan-Meier methods to construct cumulative time-to-event curves for the two groups, with a comparison by use of the log-rank test.

We used a Cox proportional hazard model analysis to control for any potential imbalance in baseline characteristics and follow-up between the two groups.

Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.82 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug), Placebo Tablet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Cox
Comments Analysis before adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.81 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug), Placebo Tablet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Cox
Comments Analysis after adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.81 to 1.03
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) Placebo Tablet
Hide Arm/Group Description

Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.

Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin

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.
All-Cause Mortality
Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) Placebo Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) Placebo Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4089 (0.00%)   0/4075 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) Placebo Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4089 (0.00%)   0/4075 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Coordinator
Organization: VITATOPS
Phone: +61892247004
EMail: julia.o'dea@health.wa.gov.au
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
VITATOPS Trial Study Group, Hankey GJ, Algra A, Chen C, Wong MC, Cheung R, Wong L, Divjak I, Ferro J, de Freitas G, Gommans J, Groppa S, Hill M, Spence D, Lees K, Lisheng L, Navarro J, Ranawaka U, Ricci S, Schmidt R, Slivka A, Tan K, Tsiskaridze A, Uddin W, Vanhooren G, Xavier D, Armitage J, Hobbs M, Le M, Sudlow C, Wheatley K, Yi Q, Bulder M, Eikelboom JW, Hankey GJ, Ho WK, Jamrozik K, Klijn K, Koedam E, Langton P, Nijboer E, Tuch P, Pizzi J, Tang M, Antenucci M, Chew Y, Chinnery D, Cockayne C, Loh K, McMullin L, Smith F, Schmidt R, Chen C, Wong MC, de Freitas G, Hankey GJ, Loh K, Song S. VITATOPS, the VITAmins TO prevent stroke trial: rationale and design of a randomised trial of B-vitamin therapy in patients with recent transient ischaemic attack or stroke (NCT00097669) (ISRCTN74743444). Int J Stroke. 2007 May;2(2):144-50. doi: 10.1111/j.1747-4949.2007.00111.x.
Layout table for additonal information
Responsible Party: VITATOPS
ClinicalTrials.gov Identifier: NCT00097669    
Other Study ID Numbers: ec550
First Submitted: November 24, 2004
First Posted: November 25, 2004
Results First Submitted: January 20, 2014
Results First Posted: September 25, 2020
Last Update Posted: September 25, 2020