Effect of vitamin D administration in critically ill vitamin D deficient patients

Not yet recruiting

• Conditions: Vitamin D deficiency, unspecified,

• Registration Number: CTRI/2019/11/022098
• Lead Sponsor: Maulana Azad Medical College and associated Lok Nayak Hospital

Brief Summary

Overthe last several years, multiple studies have demonstrated that vitamin Ddeficiency is a preexisting and acquired disorder in critical illness, and itsprevalence is probably greater than once believed.50-84% of PICUpatients may have vitamin D deficiency.

Vitamin D deficiency has been thought not only to be commonbut also a potentially modifiable risk factor for severity and clinical outcomeduring critical illness. Even a subclinicalVitamin D deficient state may predispose to neurologic, cardiovascular,respiratory and immune pathology and these organ systems are vital for earlyrecovery.

However, there isvery little literature available to support the use of vitamin D supplementationto improve morbidity and mortality in patients admitted to ICU and vitamin Ddeficiency is rarely replaced adequately, if at all, in these patients.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-10-31
• Study Start: 2019-11-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

All the children 1month to 12 years of age requiring PICU admission, who are vitamin D deficient.

Exclusion Criteria

Children with hypocalcaemia, known renal disease, urolithiasis or nephrocalcinosis, parathyroid disease or pituitary dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of single high dose vitamin D supplementation as compared to placebo on the outcome of vitamin D deficient patients admitted to PICU i.e. difference in: -	72 hours
Mortality	72 hours
Duration of PICU stay	72 hours
Need for mechanical ventilation	72 hours
Duration of ventilation in ventilated patients	72 hours
Need for cardiovascular support as boluses or inotropes.	72 hours

Secondary Outcome Measures

Name	Time	Method
Change in vitamin D levels after giving single high dose vitamin D supplementation in critically ill vitamin D deficient children	72 hours

Trial Locations

Locations (1)

Maulana Azad Medical College and associated Lok Nayak Hospital; 🇮🇳 Central, DELHI, India

Maulana Azad Medical College and associated Lok Nayak Hospital

🇮🇳Central, DELHI, India

Dr Urmila Jhamb

Principal investigator

ujhamb@hotmail.com