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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05650268
Enrollment
0
Registered
2022-12-14
Start date
2021-09-01
Completion date
2022-04-30
Last updated
2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery, Vitamin D Deficiency

Brief summary

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

Detailed description

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.

Interventions

DRUGVitamin D3

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

OTHER95% MCT

95% MCT supplement 3-7 day before surgery

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mortality rate30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026