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Comparison · NCT03035201-6a1a0e91

Multivitamin vs Multivitamin Placebo: Incidence of Mild Cognitive Impairment Among Those Free at Baseline

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Multivitamin vs Multivitamin Placebo: Incidence of Mild Cognitive Impairment Among Those Free at Baseline. Trial comparisons, record NCT03035201-6a1a0e91. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03035201-6a1a0e91

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.05760.04430.0746wilson
Risk in group 20.06090.04730.0781wilson
Risk difference, group 1 minus group 2-0.00329-0.0250.0185newcombe hybrid score
Risk ratio, group 1 over group 20.9460.6581.36log
Odds ratio, group 1 over group 20.9430.6411.39log
Number needed to treat, for one fewer participant with the outcome on Multivitamin than on Multivitamin Placebo304from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1MultivitaminDaily multivitamin53920OG000
Group 2Multivitamin PlaceboDaily multivitamin placebo57936OG001

Outcome

Type
SECONDARY
Title
Incidence of Mild Cognitive Impairment Among Those Free at Baseline
Description
Mild cognitive impairment based on central adjudication of test scores with input from proxies. Based on test scores administered annually across 3 years.
Time frame
From baseline through year 3
Population
Participants free of mild cognitive impairment at baseline. In a factorial design such as this, primary comparisons are cocoa flavanol vs cocoa flavanol placebo (pooling across multivitamin and multivitamin placebo) and multivitamin vs multivitamin placebo (pooling across cocoa flavanol and cocoa flavanol placebo). To provide outcomes for the four cells does not conform with the protocol or the published results and will not be consistent with the statistical analysis plan.

Source ClinicalTrials.gov

Trial

Title
COcoa Supplement and Multivitamin Outcomes Study for the Mind
NCT number
NCT03035201
Phases
Conditions
Cognitive Impairment, Dementia, Aging
Interventions
Lead sponsor
Wake Forest University Health Sciences
Results first posted
2023-08-22

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
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

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone 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.

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