Trial Outcomes & Findings for VITATOPS: A Study of VITAmins TO Prevent Stroke (NCT NCT00097669)
NCT ID: NCT00097669
Last Updated: 2020-09-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8164 participants
Primary outcome timeframe
The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).
Results posted on
2020-09-25
Participant Flow
Participant milestones
| Measure |
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.
Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4089
|
4075
|
|
Overall Study
COMPLETED
|
4089
|
4075
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VITATOPS: A Study of VITAmins TO Prevent Stroke
Baseline characteristics by cohort
| Measure |
Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)
n=4089 Participants
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 Tablet
n=4075 Participants
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
n=8164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 Years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
62.6 Years
STANDARD_DEVIATION 12.4 • n=107 Participants
|
62.6 Years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1475 Participants
n=99 Participants
|
1471 Participants
n=107 Participants
|
2946 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2614 Participants
n=99 Participants
|
2604 Participants
n=107 Participants
|
5218 Participants
n=206 Participants
|
|
Functional severity of qualifying stroke
Independent (Oxford handicap score 0-3)
|
3035 participants
n=99 Participants
|
3024 participants
n=107 Participants
|
6059 participants
n=206 Participants
|
|
Functional severity of qualifying stroke
Dependent (Oxford handicap score 3,4 or 5)
|
951 participants
n=99 Participants
|
943 participants
n=107 Participants
|
1894 participants
n=206 Participants
|
|
past history of stroke, prior to qualifying stroke or transient ischemic attack (TIA)
|
624 participants
n=99 Participants
|
658 participants
n=107 Participants
|
1282 participants
n=206 Participants
|
|
laboratory results for fasting homocysteine
|
14.4 micromoles per liter
STANDARD_DEVIATION 9.2 • n=99 Participants
|
14.2 micromoles per liter
STANDARD_DEVIATION 7.7 • n=107 Participants
|
14.3 micromoles per liter
STANDARD_DEVIATION 8.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).Population: Intention to treat analysis population of all patients randomised (n=8164)
Outcome measures
| Measure |
Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)
n=4089 Participants
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 Tablet
n=4075 Participants
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.
|
|---|---|---|
|
Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes
|
616 Participants
|
678 Participants
|
Adverse Events
Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place