Ontology highlight
ABSTRACT:
Design: Post hoc analysis of a randomized double-blind placebo-controlled trial.
Setting: Forty Women's Health Initiative (WHI) clinical centers across the United States.
Participants: Four thousand one hundred forty-three women aged 65 and older without probable dementia at baseline who participated in the WHI Calcium and Vitamin D Trial and the WHI Memory Study.
Intervention: Two thousand thirty-four women were randomized to receive 1,000 mg of calcium carbonate combined with 400 IU of vitamin D(3) (treatment) and 2,109 to placebo.
Measurements: Primary: classifications of probable dementia or mild cognitive impairment (MCI) based on a four-phase protocol that included central adjudication. Secondary: global cognitive function and individual cognitive subtests.
Results: Mean age of participants was 71. During a mean follow-up of 7.8 years, 39 participants in the treatment group and 37 in the placebo group developed incident dementia (hazard ratio (HR) = 1.11, 95% confidence interval (CI) = 0.71-1.74, P = .64). Likewise, 98 treatment participants and 108 placebo participants developed incident MCI (HR = 0.95, 95% CI = 0.72-1.25, P = .72). There were no significant differences in incident dementia or MCI or in global or domain-specific cognitive function between groups.
Conclusion: There was no association between treatment assignment and incident cognitive impairment. Further studies are needed to investigate the effects of vitamin D and calcium separately, on men, in other age and ethnic groups, and with other doses.
SUBMITTER: Rossom RC
PROVIDER: S-EPMC3521077 | biostudies-literature | 2012 Dec
REPOSITORIES: biostudies-literature
Rossom Rebecca C RC Espeland Mark A MA Manson Joann E JE Dysken Maurice W MW Johnson Karen C KC Lane Dorothy S DS LeBlanc Erin S ES Lederle Frank A FA Masaki Kamal H KH Margolis Karen L KL
Journal of the American Geriatrics Society 20121123 12
<h4>Objectives</h4>To examine the effects of vitamin D and calcium on cognitive outcomes in elderly women.<h4>Design</h4>Post hoc analysis of a randomized double-blind placebo-controlled trial.<h4>Setting</h4>Forty Women's Health Initiative (WHI) clinical centers across the United States.<h4>Participants</h4>Four thousand one hundred forty-three women aged 65 and older without probable dementia at baseline who participated in the WHI Calcium and Vitamin D Trial and the WHI Memory Study.<h4>Inter ...[more]