Does taking vitamin D3 before esophageal surgery reduce the risk of lung complications?

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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15385525

Enrollment

100

Registered

2025-01-31

Start date

2019-01-01

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

Esophageal cancer, acute respiratory distress syndrome Cancer

Interventions

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. S

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Slovakia

Contacts

Public ContactMartin Lucenic

martin.lucenic@ru.unb.sk+421 248234408

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026