Objective Our study aimed to assess the effect of a 12-month vitamin D supplementation on cognitive function and amyloid beta (Aβ)-related biomarkers in subjects with Alzheimer’s disease (AD).
Methods This was a randomised, double-blind, placebo-controlled trial. 210 AD patients were randomly divided into intervention and control groups. Participants received 12-month 800 IU/day of vitamin D or starch granules as placebo. Tests of cognitive performance and Aβ-related biomarkers were measured at baseline, 6 months and 12 months.
Results Repeated-measures analysis of variance showed significant improvements in plasma Aβ42, APP, BACE1, APPmRNA, BACE1mRNA (p<0.001) levels and information, arithmetic, digit span, vocabulary, block design and picture arrange scores (p<0.05) in the intervention group over the control group. According to mixed-model analysis, vitamin D group had significant increase in full scale IQ during follow-up period (p<0.001).
Conclusions Daily oral vitamin D supplementation (800 IU/day) for 12 months may improve cognitive function and decrease Aβ-related biomarkers in elderly patients with AD. Larger scale longer term randomised trials of vitamin D are needed.
Trial registration number ChiCTR-IIR-16009549.
- Alzheimer’s disease
- vitamin D
- cognitive function
- randomised controlled trial
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Contributors FM designed the research. JH conducted the research. RH and XH provided essential reagents. JJ and YZ performed the statistical analysis. JJ wrote the paper. All authors revised the manuscript and approved the final version to be published.
Funding This study was supported by the National Natural Science Foundation of China (grant number: 81573148; 81874261).
Competing interests None declared.
Patient consent for publication All subjects signed informed consent prior to study initiation.
Ethics approval This study adheres to the principles of the Declaration of Helsinki. The protocol was approved by the Ethics Committees of Tianjin Medical University, China.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available.
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