Effect of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors: a Randomized Controlled Study
| Registry | NCT05552729 |
|---|---|
| Status | Unknown |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 114 (Estimated) |
| Sponsor | Yangzhou University (Other); collaborators: Subei People's Hospital of Jiangsu Province |
| Conditions | Gastrointestinal Neoplasms, Cognitive Impairment |
| Interventions | Vitamin D (Drug) |
| Dates | start 2022-09-22 (estimated), primary completion 2022-12-30 (estimated), completion 2022-12-30 (estimated), first posted 2022-09-23, last updated 2022-09-23 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Gastrointestinal Neoplasms All trials for Cognitive Impairment All trials of Vitamin D
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| High dose group | Active comparator | Drug: Vitamin D | A 2000IU vitamin D3 supplement was started the next day after surgery. |
| Low dose group | Active comparator | Drug: Vitamin D | A 400IU vitamin D3 supplement was started the next day after surgery. |
| The control group. | No intervention | No vitamin D3 supplement was started the next day after surgery. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Daorong Wang | Yangzhou, Jiangsu | China |