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

NCT03320109 | Completed

• 1 other identifier: NIA2
• Study Type: observational
• Target: 3,720
• Locations: 1 country
• Sites: 1

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).

Conditions

Cognitive Decline; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Cognitive change

  Annual rate of change in cognitive test scores spanning several domains of cognition

  Over a mean of 4.8 y

Interventions

Vitamin D OTHER

Also known as: Serum 25(OH)D status and dietarysupplemental vitamin D

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

Biomedical Research Center, NIA/NIH/IRP

Baltimore, Maryland, 21224, United States

Location

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Related Links

• S Department of Agriculture ARS, Food Surveys Research Group. USDA Food and Nutrient Database for Dietary Studies, 3.0
• Centers for Disease Control and Prevention
• STATA. Statistics/Data Analysis: Release 15.0. Texas: Stata Corporation, 2017
• Selvin S. Statistical Analysis of Epidemiologic Data. 3rd ed: Oxford University Press, 2004.
• Hochberg Y, Tamhane, A. C.,. Multiple comparison procedures. New York: Wiley, 1987.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Scientist

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 25, 2017
• Study Start: August 18, 2004
• Primary Completion: July 7, 2013
• Study Completion: July 7, 2013
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)