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

NCT05650268 | Withdrawn

• 1 other identifier: 201808006RIPC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vitamin D Deficiency; Surgery

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  30 days

Study Arms (2)

Vitamin D3

EXPERIMENTAL

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

Drug: Vitamin D3

Control group

PLACEBO COMPARATOR

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

Other: 95% MCT

Interventions

Vitamin D3 DRUG

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

Also known as: Vitamin D

Vitamin D3

95% MCT OTHER

95% MCT supplement 3-7 day before surgery

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Adult patients who will receive general surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Yin-Yi Han, MD,PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: December 14, 2022
• Study Start: September 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 30, 2022
• Last Updated: December 14, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share