Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaoyuan General Hospital

About this trial

High concentrations of parathyroid hormone (PTH) are common in patients with hepatocellular carcinoma (HCC). This study is aimed to investigate effects of vitamin D status and its multiple mega-dosage supplementation on PTH and clinical outcomes in HCC patients before and after hepatectomy. It's a single-center, prospective, parallel, double-blind, placebo-controlled study for 120 eligible subjects. The subjects will receive consecutively 3-day intervention treatments from 7th day before surgery. 30-day postoperative mortality, postoperative complications, and laboratory data will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy

2.Sign the informed consent

Disqualifiers

1. Using estrogen drugs, bisphosphonates, or drugs for bone disease.

2. Consume calcium tablets within 2 weeks before operation

3. Sarcoidosis, multiple myeloma

4. Pregnant women or plan to become pregnant within 3 months after surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D

    Other intervention

    Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days

  • Placebo

    Other intervention

    Oral supplementation of placebo in 3 consecutive days.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Vitamin D groupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association

Time frame
During the study period
2

Ratio of liver failure

Time frame
7 days pre- OP (day -7)
3

Ratio of liver failure

Time frame
1 day pre- OP (day -1)
4

Ratio of liver failure

Time frame
1 day post- OP (day 1)

Secondary outcomes

1

25(OH)D status

Time frame
Baseline (day -7), day -1, day 1 and 1 day before discharge
2

Prevalence of high PTH

Time frame
Baseline (day -7), day -1, day 1 and 1 day before discharge
3

Prevalence of hypercalcemia

Time frame
Baseline (day -7), day -1, day 1 and 1 day before discharge
4

Prevalence of hypomagnesemia

Time frame
Baseline (day -7), day -1, day 1 and 1 day before discharge

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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