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Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors

Effect of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors: a Randomized Controlled Study

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05552729
Enrollment
114
Registered
2022-09-23
Start date
2022-09-22
Completion date
2022-12-30
Last updated
2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Gastrointestinal Neoplasms

Keywords

Gastrointestinal Neoplasms, Cognitive Impairment, Vitamin D

Brief summary

To explore the effect of different doses of vitamin D drugs on gastrointestinal cancer cancer-related cognitive impairment, so as to provide reference and basis for the clinical use of our cognitive function surgery nursing plan for patients with gastrointestinal cancer.

Detailed description

To determine the incidence of postoperative cognitive dysfunction in patients with gastrointestinal tumors to determine the influencing factors of postoperative cognitive dysfunction in patients with gastrointestinal tumors. The characteristics of perioperative cancer-related cognitive impairment in patients with gastrointestinal tumors were analyzed by monitoring preoperative and postoperative FACT-COG cognitive scale connection test (Hua-Shan-version auditory word learning test) DSST digit symbol test gaffes detection task and hematology indexes, such as observation and analysis of the interference pattern of supplement vitamin D preparation postoperative hospital stay in patients with gastrointestinal tumor short-term cognitive impairment related to cancer, in order to reduce the incidence of complications and hospitalization days, improve cognitive function in patients with gastrointestinal tumor surgery, and improve the quality of nursing.

Interventions

DRUGVitamin D

The patients were given vitamin D supplementation 48 hours after surgery, and the two groups were given different doses of vitamin D supplementation until the postoperative discharge criteria were met. To scientifically evaluate the application effect of early postoperative vitamin D intervention in the improvement of perioperative cognitive function in patients with gastrointestinal tumors.

Sponsors

Subei People's Hospital of Jiangsu Province
CollaboratorOTHER
Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with gastrointestinal tumors diagnosed by gastroscopy and histology and their family members * Elective surgery * Education level in primary school or above * Be able to fill in the questionnaire alone or under the guidance of the researcher * Informed consent and voluntary participation in this study

Exclusion criteria

* Patients with cognitive impairment (illiteracy less than 17 points, primary school less than 20 points, secondary school or above less than 24 points) or previous history of cognitive impairment, dementia and delirium confirmed by MMSE examination before surgery * Patients with life-threatening acute and chronic diseases * Patients with eye or ear diseases leading to rapid loss of hearing or vision without AIDS * Patients who have taken drugs related to improving cognitive function or drugs for psychiatric disorders * Patients who cannot take care of themselves or are physically disabled and unable to perform neurological function tests * Intraoperative hypoxemia (blood oxygen saturation \< 94%) more than 10 minutes * Patients who quit or died due to non-cooperation or emergency

Design outcomes

Primary

MeasureTime frameDescription
Cognitive functionEight days after the surgeryFact-cog Cognitive Scale.The higher the score, the better the cognition.

Secondary

MeasureTime frameDescription
SleepEight days after the surgeryPittsburgh sleep quality index.The overall score ranges from 0 to 21, with a score of 0 to 5 indicating good sleep quality,6 to 10 indicating fair sleep quality,11 to 15 indicating fair sleep quality, and 16 to 21 indicating very poor sleep quality.
Cancer related fatigueEight days after the surgeryCancer Fatigue Scale. The total score ranges from 0 to 15, and 4 is considered frailty.
AstheniaEight days after the surgeryGroningen Frailty Indicator. The total score ranges from 0 to 15, and 4 is considered frailty.

Countries

China

Contacts

Primary ContactDaorong Wang, Professor
wangdaorong666@sina.com18051062590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026