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Effect of Early High-Dose Vitamin D3 Repletion on Cognitive Outcomes in Critically Ill Adults.
|Title||Effect of Early High-Dose Vitamin D3 Repletion on Cognitive Outcomes in Critically Ill Adults.|
|Publication Type||Journal Article|
|Year of Publication||2021|
|Authors||Han JH, Ginde AA, Brown SM, Baughman A, Collar EM, E Ely W, Gong MN, Hope AA, Hou PC, Hough CL, Iwashyna TJ, Jackson JC, Khan A, Orun OM, Patel MB, Raman R, Rice TW, Ringwood N, Semler MW, Shapiro NI, Talmor DS, Self WH|
|Corporate Authors||Vitamin D to Improve Outcomes by Leveraging Early Treatment Network Investigators|
|Date Published||2021 Sep|
|Keywords||Cholecalciferol, Cognition, Cognitive Dysfunction, Critical Illness, Executive Function, Female, Humans, Long Term Adverse Effects, Male, Middle Aged, Neuropsychological Tests, Pulse Therapy, Drug, Treatment Outcome, Vitamin D Deficiency, Vitamins|
BACKGROUND: Long-term cognitive impairment frequently occurs after critical illness; no treatments are known to improve long-term cognition.RESEARCH QUESTION: Does a single high-dose (540,000 International Units) enteral treatment of vitamin D3 given shortly after hospital admission in critically ill patients who are vitamin D deficient improve long-term global cognition or executive function?STUDY DESIGN AND METHODS: This study evaluated long-term cognitive outcomes among patients enrolled in a multicenter, blinded, randomized clinical trial comparing vitamin D3 treatment vs placebo in critically ill adults with vitamin D deficiency. Global cognition was measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Executive function was measured with a composite score derived from three Delis-Kaplan Executive Function System subscales. Outcomes were assessed at a median of 443 days (interquartile range, 390-482 days) after randomization and were compared using multivariate proportional odds regression. Adjusted ORs of > 1.0 would indicate better outcomes in the vitamin D3 group compared with the placebo group.RESULTS: Ninety-five patients were enrolled, including 47 patients randomized to vitamin D3 treatment and 48 patients randomized to placebo. The adjusted median RBANS score at follow-up was 79.6 (95% CI, 73.0-84.0) in the vitamin D3 group and 82.1 (95% CI, 74.7-84.6) in the placebo group (adjusted OR, 0.83; 95% CI, 0.50-1.38). The adjusted median executive function composite scores were 8.1 (95% CI, 6.8-9.0) and 8.7 (95% CI, 7.4-9.3), respectively (adjusted OR, 0.72; 95% CI, 0.36-1.42).INTERPRETATION: In vitamin D-deficient, critically-ill adults, a large dose of enteral vitamin D3 did not improve long-term global cognition or executive function.TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03733418; URL: www.clinicaltrials.gov.
|PubMed Central ID||PMC8449000|
|Grant List||K23 HL143053 / HL / NHLBI NIH HHS / United States |
R56 HL141567 / HL / NHLBI NIH HHS / United States
UL1 TR000445 / TR / NCATS NIH HHS / United States