Does taking vitamin D3 before esophageal surgery reduce the risk of lung complications?
| ISRCTN | ISRCTN15385525 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15385525 |
| Secondary identifying numbers | No EC/193/2018 |
- Submission date
- 16/12/2024
- Registration date
- 31/01/2025
- Last edited
- 29/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Oesophageal cancer is a major cause of cancer-related deaths worldwide. The main treatment is esophagectomy, a complex surgery with high risks. Up to 40% of patients experience complications after surgery, especially lung issues like pneumonia and acute respiratory distress syndrome (ARDS). This study investigates whether taking a high dose of vitamin D3 before surgery can reduce the risk of these lung complications.
Who can participate?
Adults over 18 years old with oesophageal cancer scheduled for esophagectomy can participate in this study.
What does the study involve?
Participants are randomly assigned to receive either a single high dose of vitamin D3 or a placebo before their surgery. The study monitors their lung health and recovery after the operation.
What are the possible benefits and risks of participating?
The potential benefit is a reduced risk of lung complications after surgery. The risks are minimal since vitamin D3 is generally safe, but there may be some side effects from the high dose.
Where is the study run from?
University Hospital Bratislava (Slovakia)
When is the study starting and how long is it expected to run for?
September 2018 to June 2025
Who is funding the study?
The study is funded by the Slovak Society of Anesthesia & Intensive Care Medicine.
Who is the main contact?
Dr Katarina Tarabova, katarina.tarabova@ru.unb.sk
Contact information
Scientific, Principal Investigator
University Hospital
Ruzinovska 6
Bratislava
82606
Slovakia
 ORCID ID |
0009-0006-3718-4087 |
|---|---|
| Phone | +421 48234503 |
| katarina.tarabova@ru.unb.sk |
Public
University Hospital Bratislava
Ruzinovska 6
Bratislava
82606
Slovakia
| ORCID ID |
0000-0003-2468-7604 |
|---|---|
| Phone | +421 248234408 |
| martin.lucenic@ru.unb.sk |
Study information
| Study design | Randomized double-blind placebo-controlled Phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 46565 PATIENT INFORMATION AND INFORMED CONSENT.pdf |
| Scientific title | The association between preoperative single high-dose vitamin D3 supplementation and ARDS (Acute respiratory distress syndrome) incidence in patients after esophageal resection for carcinoma- a randomised, placebo-controlled trial (ESOVID) |
| Study acronym | ESOVID |
| Study hypothesis | The study aims to investigate whether preoperative supplementation with oral cholecalciferol would reduce the risk of ARDS development following oesophagectomy, as measured by the extravascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI). |
| Ethics approval(s) |
Approved 26/09/2018, The Local Ethics Committee, University Hospital Bratislava (Ruzinovska 6, Bratislava, 82606, Slovakia; +421 248234793; okf@ru.unb.sk), ref: No EC/193/2018 |
| Condition | Esophageal cancer, acute respiratory distress syndrome |
| Intervention | Randomisation Process - Randomisation Method: Patients were randomised using a dice. An even number assigned patients to the treatment group, while an odd number assigned them to the placebo group. Study Arms 1. Treatment Group - Number of Patients: 40 - Treatment: - 3-5 days before surgery: 300,000 IU of vitamin D3 (15 ml) - Day of Surgery: Standard surgical procedures - Postoperative Days (POD) 1 to 6: Monitoring and evaluations - Measurements: - Calcium & 25-OH vitamin D plasma levels - Extravascular Lung Water Index (EVLWI) & Pulmonary Vascular Permeability Index (PVPI) after catheterisation and 1 hour postoperatively - One-lung ventilation (OLV) duration - Tidal volume during OLV - Amount of intraoperative fluid administration - Follow-Up: - POD1: EVLWI & PVPI measurements - POD1 to POD6: Sequential Organ Failure Assessment (SOFA) evaluation - POD6: Calcium & 25-OH vitamin D plasma levels 2. Placebo Group - Number of Patients: 40 - Treatment: - 3-5 days before surgery: Medium-chain triglyceride (MCT) oil (15 ml) - Day of Surgery: Standard surgical procedures - Postoperative Days (POD) 1 to 6: Monitoring and evaluations - Measurements: - Calcium & 25-OH vitamin D plasma levels - EVLWI & PVPI after catheterisation and 1 hour postoperatively - OLV duration - Tidal volume during OLV - Amount of intraoperative fluid administration - Follow-Up: - POD1: EVLWI & PVPI measurements - POD1 to POD6: SOFA evaluation - POD6: Calcium & 25-OH vitamin D plasma levels Summary - Total Duration of Treatment: 3-5 days before surgery to POD6 - Follow-Up Duration: From the day of surgery to POD6 - Randomisation Details: Dice roll (even for treatment, odd for placebo) |
| Intervention type | Supplement |
| Primary outcome measure | 1. Extravascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI) evaluation one hour postoperatively and on postoperative Day 1. 2. Acute respiratory distress syndrome incidence during the hospital stay. |
| Secondary outcome measures | 1. Impact of cholecalciferol supplementation on vitamin D3 plasma levels at surgery day and postoperative day 6. 2. Effect of preoperative cholecalciferol supplementation on the need for mechanical ventilation and its duration of mechanical ventilation duration in patients with respiratory failure. 3. Effect of preoperative cholecalciferol supplementation on SOFA score. 4. Effect of preoperative cholecalciferol supplementation on the presence of respiratory complications. 5. Effect of preoperative cholecalciferol supplementation on length of ICU stay. 6. Effect of preoperative cholecalciferol supplementation on 30 and 90-day mortality. 7. Effect of preoperative cholecalciferol supplementation on 3-year survival. |
| Overall study start date | 26/09/2018 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 84 |
| Participant inclusion criteria | 1. Patients over 18 years old 2. Planned transthoracic oesophagectomy for oesophageal carcinoma 3. One-lung ventilation during operation 4. Ability to obtain written consent for participation in the study |
| Participant exclusion criteria | 1. Known intolerance to oral cholecalciferol 2. Inability to swallow 3. Known sarcoidosis, hyperparathyroidism, or nephrolithiasis 4. Serum calcium >2.65 mmol/l 5. Undergoing haemodialysis 6. Pregnant or breastfeeding 7. Diagnosis of chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in one second (FEV1) less than 50% predicted or resting oxygen saturation of less than 92% 8. Oesophageal resection without the use of OLV 9. Failure to obtain informed consent |
| Recruitment start date | 01/01/2019 |
| Recruitment end date | 30/06/2022 |
Locations
Countries of recruitment
- Slovakia
Study participating centre
Bratislava
82606
Slovakia
Sponsor information
Hospital/treatment centre
Ruzinovska 6
Bratislava
82606
Slovakia
| Phone | +421 248234111 |
|---|---|
| hovorca@unb.sk | |
| Website | https://www.unb.sk/ |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Dr Katarina Tarabova, PhD., e-mail: katarina.tarabova@ru.unb.sk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in English | 29/01/2025 | No | Yes | |
| Participant information sheet | in Slovak | 29/01/2025 | No | Yes |
Additional files
Editorial Notes
29/01/2025: Trial's existence confirmed by Slovak Society of Anaesthesia and Intensive Medicine.
