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

NCT ID: NCT05552729

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-22

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Neoplasms Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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High dose group

A 2000IU vitamin D3 supplement was started the next day after surgery.

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

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.

Low dose group

A 400IU vitamin D3 supplement was started the next day after surgery.

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

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.

The control group.

No vitamin D3 supplement was started the next day after surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin 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.

Intervention Type DRUG

Other Intervention Names

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Different doses of vitamin D

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Subei People's Hospital of Jiangsu Province

OTHER

Sponsor Role collaborator

Yangzhou University

OTHER

Sponsor Role lead

Responsible Party

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Wang Daorong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daorong Wang, Professor

Role: STUDY_DIRECTOR

Yangzhou University

Locations

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Daorong Wang

Yangzhou, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Daorong Wang, Professor

Role: CONTACT

18051062590

Other Identifiers

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Yangzhou University

Identifier Type: -

Identifier Source: org_study_id

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