NCT05552729

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

September 22, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 3, 2022

Last Update Submit

September 20, 2022

Conditions

Gastrointestinal NeoplasmsCognitive Impairment

Keywords

Gastrointestinal NeoplasmsCognitive ImpairmentVitamin D

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Fact-cog Cognitive Scale.The higher the score, the better the cognition.

    Eight days after the surgery

Secondary Outcomes (3)

  • Sleep

    Eight days after the surgery

  • Cancer related fatigue

    Eight days after the surgery

  • Asthenia

    Eight days after the surgery

Study Arms (3)

High dose group

ACTIVE COMPARATOR

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

Drug: Vitamin D

Low dose group

ACTIVE COMPARATOR

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

Drug: Vitamin D

The control group.

NO INTERVENTION

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

Interventions

Vitamin DDRUG

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.

Also known as: Different doses of vitamin D
High dose groupLow dose group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daorong Wang

Yangzhou, Jiangsu, 225009, China

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsCognitive Dysfunction

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Daorong Wang, Professor

    Yangzhou University

    STUDY DIRECTOR

Central Study Contacts

Daorong Wang, Professor

CONTACT

18051062590wangdaorong666@sina.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 23, 2022

Study Start

September 22, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)