Does high dose Vitamin D use in patients of infection and organ dysfunction with low Vitamin D level improve survival
- Conditions
- Health Condition 1: R652- Severe sepsis
- Registration Number
- CTRI/2019/05/018910
- Lead Sponsor
- Postgraduate Institute of Medical Education and Research Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age more than or equal to 18 years
2. Documented Vitamin Vitamin D levels less than 30 ng/ml
3. Increase in Sequential Organ Failure Assessment (SOFA) score of 2 along-with documented source of infection anywhere, either clinically or by laboratory/radiological investigation/s.
1.Age less than 18 years
2.Pregnancy
3.Those who are taking calcium or Vitamin D supplementation
4.Known case of chronic renal failure, disorders of malabsorption, disorders of the thyroid
5.Those who are on drugs affecting Vitamin D levels such as antitubercular therapy, antiepileptics, ketoconazole (interference with hydroxylation in the liver)
6.Those who are on oral or parenteral steroids for more than 3 months (daily dose of 5 mg of prednisolone or its equivalents and a cumulative dose of more than 1 gram
7.Immobilization in the last 6 months
8.Those who are not giving written consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine reduction in hospital and 30 day mortality in patients with confirmed diagnosis of sepsis with deficient vitamin D levels at admission receiving large dose of vitamin D enteral supplementation as compared to low doseTimepoint: Hospital and 30 day mortality
- Secondary Outcome Measures
Name Time Method Secondary objectives are to ascertain the effectiveness of high dose enteral bolus of vitamin D supplementation on <br/ ><br>1. Duration of mechanical ventilation <br/ ><br>2. Requirement of renal replacement therapy <br/ ><br>3. Requirement of vasoactive agents and duration of such need <br/ ><br>4. Trends of biochemical and endocrine variables relevant to calcium- and phosphorus metabolism; <br/ ><br>5. Trends of inflammatory markers like ESR, C-Reactive Protein and procalcitonin levels <br/ ><br>Timepoint: At admission, during hospital stay