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Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery

NCT ID: NCT05650268

Last Updated: 2022-12-14

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-04-30

Brief Summary

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To investigate whether preoperative supplement with high-dose vitamin D3 can reduce the perioperative risk and enhance recovery

Detailed Description

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Perioperative management for risk reduction in patients undergoing major surgery are taken increasingly important nowadays. The patient factor (age and comorbidities mainly), type of surgery and extent of tissue injury are major contributions to the development perioperative complications. From nutrition support to nutrition therapy, a comprehensive nutrition plays a pivotal role to optimize the above three key factors and hence reduce the perioperative risk. Vitamin D, a pleiotropic hormone with extensive physiological effect, is one of the nutrients critical to perioperative outcomes. It not only meets the essential demand of surgical patients, such as wound care, infection control, metabolic support and organ support, but also attenuates oxidative stress, modulates dys-inflammation and repair the damaged organelles like telomere and mitochondria. This is a double-blind, randomized controlled trial in a single center. Sixty eligible adult patients who will undergo general surgery are to be included.

The experimental group will receive 576000 IU in single oral dose of liquid vitamin D 3\~7 days prior to the surgery. The primary endpoint is rapid recovery index, such as bowel recovery, pain control, sedation and fatigue assessment. The secondary endpoints include perioperative inflammatory indexes, hemodynamic parameters, glycemic control as well as safety evaluation of vitamin D.

Conditions

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Vitamin D Deficiency Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D3

The experimental group will receive 576000 IU in single oral dose of liquid vitamin D3\~7 days prior to the surgery.

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

Receiving 576000 international units in single oral dose of liquid vitamin D 3\~7 days prior to the surgery.

Control group

The control group will receive 95% MCT D3\~7 days prior to the surgery.

Group Type PLACEBO_COMPARATOR

95% MCT

Intervention Type OTHER

95% MCT supplement 3-7 day before surgery

Interventions

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Vitamin D3

Receiving 576000 international units in single oral dose of liquid vitamin D 3\~7 days prior to the surgery.

Intervention Type DRUG

95% MCT

95% MCT supplement 3-7 day before surgery

Intervention Type OTHER

Other Intervention Names

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Vitamin D

Eligibility Criteria

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Inclusion Criteria

* 20 years or older
* Adult patients who will receive general surgery

Exclusion Criteria

* Chronic liver diseases
* Hypercalcemia
* Using estrogen drug, bisphosphonate, other durgs to treat bone diseases
* Sarcoidosis, Multiple myeloma or Primary hyperparathyroidism
* Pregnant women
* Other trial participation
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yin-Yi Han, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Other Identifiers

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201808006RIPC

Identifier Type: -

Identifier Source: org_study_id