Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) vs Placebo Tablet: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.151 | 0.14 | 0.162 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.166 | 0.155 | 0.178 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0157 | -0.0316 | 0.000115 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.905 | 0.819 | 1 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.889 | 0.789 | 1 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) than on Placebo Tablet | 63.6 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | 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 | 616 | 4,089 | OG000 | ClinicalTrials.gov |
| Group 2 | 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. | 678 | 4,075 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes | ClinicalTrials.gov |
| Description | ClinicalTrials.gov | |
| 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). | ClinicalTrials.gov |
| Population | Intention to treat analysis population of all patients randomised (n=8164) | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | VITATOPS: A Study of VITAmins TO Prevent Stroke | ClinicalTrials.gov |
| NCT number | NCT00097669 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Stroke, Transient Ischemic Attack | ClinicalTrials.gov |
| Interventions | Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo, Placebo | ClinicalTrials.gov |
| Lead sponsor | VITATOPS | ClinicalTrials.gov |
| Results first posted | 2020-09-25 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00097669?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.