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Ultra dose vitamin D supplementation in ventilator associated pneumonitis (VAP) patients

Effects of ultra dose vitamin D supplementation on remission, morbidity and mortality of ventilator associated pneumonitis (VAP) patients: A Randomized Controlled Trial study.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200324046844N1
Enrollment
42
Registered
2020-05-19
Start date
2020-04-29
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Ventilator associated pneumonitis (VAP).

Interventions

Intervention 1: Intervention group: 2 cc/day vitamin D with the dose of 100000 units orally for five days from Zahravi drug company. Intervention 2: Control group: 2 cc/day olive oil as placebo for fi

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Pneumonia Severity Index (PSI) score above 51 The level of vitamin D below 20 ng/ml at the admission to the hospital Absence of hypercalcemia at the admission to the hospital (calcium concentration above 10.8 mg/dl) Stable hemodynamic status Not consuming hydrochlorothiazide, digoxin and magnesium containing antacids Absence of history of consuming vitamin D during the past four months with the dose above 1000 units Able to be be fed enterally at the 24 to 48 hours from the admission time Signing the consent form by the family of patients Absence of any of these disease: hyperparathyroidism, nephrolithiasis, sarcoidosis, chronic kidney disease, cirrhosis, metabolic diseases, acquired immune deficiency syndrome (AIDS), cardiovascular disease, diabetes mellitus, cancers and autoimmune diseases Not being pregnant Not involved in other research projects

Exclusion criteria

Exclusion criteria: Presence of other types of pneumonitis Dying earlier than 7 days of intervention Presence of any condition leading to enteral feeding disruption during the first 5 days of intervention If the supplementation is thought to be hazardous or being forbidden by the general practitioner

Design outcomes

Primary

MeasureTime frame
Morbidity and organ failure calculated by the Sequential Organ Failure Assessment (SOFA) score, mortality risk assessed by the Acute Physiology and Chronic Health Enquiry (APACHE-II) score and change in the Pneumonia Severity Index (PSI) score. Timepoint: Completing the questionnaires and telephone contact about death after releasing from hospital in the 28 days after intervention. Method of measurement: SOFA, APACHE-II and PSI questionnaire and mortality numbers by telephone for released patients.

Secondary

MeasureTime frame
SOFA, APACHE-II and mortality rate. Timepoint: On day 0, 7 and 14 of the intervention. Method of measurement: On day 0, 7 and 14 of the beginning of the intervention we will complete the SOFA & APACHE-II questionnaire and on day 28 we will ask the family of the patients for death after releasing from hospital.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Abolfazl Azariyan

Shiraz University of Medical Sciences

abolfazlazariyan1@gmail.com+98 61 4255 8194

Outcome results

None listed

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