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Serum, Dietary and Supplemental Vitamin D's Association With Cognitive Decline

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ClinicalTrials.gov Identifier: NCT03320109
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
May Ahmad Baydoun, National Institute on Aging (NIA)

Brief Summary:
Serum 25(OH)D, dietary and supplemental vitamin D were shown to influence cognitive outcomes in large epidemiological studies. Sex/age-specific and race-specific associations of vitamin D status and intake were examined with longitudinal change in various cognitive domains in a large sample of ethnically and socio-economically diverse US urban adults. Two prospective waves of data from Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study were used, specifically visit 1: 2004-2009 and visit 2: 2009-2013, mean follow-up time±SD: 4.64±0.93y. Cognitive performance was assessed using 11 test scores covering domains of global cognition, attention, learning/memory, executive function, visuo-spatial/visuo-construction ability, psychomotor speed and language/verbal. Serum 25(OH)D, vitamin D intake and use of supplements containing vitamin D were the key exposures. Multiple mixed-effects linear regression models were conducted, (N=1,231-1,803, k=1.5-2.0 observation/participant).

Condition or disease Intervention/treatment
Cognitive Decline Cognitive Impairment Other: Vitamin D

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Study Type : Observational
Actual Enrollment : 3720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vitamin D Status and Intakes and Their Association With Cognitive Trajectory in a Longitudinal Study of Urban Adults
Actual Study Start Date : August 18, 2004
Actual Primary Completion Date : July 7, 2013
Actual Study Completion Date : July 7, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D


Intervention Details:
  • Other: Vitamin D
    Other Name: Serum 25(OH)D status and dietarysupplemental vitamin D


Primary Outcome Measures :
  1. Cognitive change [ Time Frame: Over a mean of 4.8 y ]
    Annual rate of change in cognitive test scores spanning several domains of cognition



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Serum 25(OH)D was lower among African-Americans who had a higher prevalence of vitamin D deficiency compared with Whites, in addition to consuming a smaller amount of vitamin D in the diet. Older participants tended to have a significant increase in serum 25(OH)D over time compared with younger men. Finally, older participants were more likely than younger men to be vitamin D-containing supplement users.
Criteria

Inclusion Criteria:

  • HANDLS initially recruited 3,720 participants (Phase I, visit 1). Given that only Phase II had in-depth data including biochemical indices and cognitive performance measures, 25(OH)D was available for 1,981 participants at baseline. The corresponding sample size for dietary and supplemental vitamin D were N=2,177 and N=2,159, respectively. Complete and reliable cognitive tests at each visit varied in sample size as well. Further, the final analytic sample was determined based on exposure and covariate non-missingness at baseline and outcome non-missingness at either visit. The final analytic sizes ranged between N=1,231 and N=1,803 with k=1.5-1.9 observation/participant.

Exclusion Criteria:

  • HANDLS participants with missing data on cognitive test score on both visits and/or missing data on exposure and covariates included in the mixed-effects regression models.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320109


Locations
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United States, Maryland
Biomedical Research Center, NIA/NIH/IRP
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Aging (NIA)
Additional Information:
Publications:

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Responsible Party: May Ahmad Baydoun, Staff Scientist, National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT03320109    
Other Study ID Numbers: NIA2
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents