a study to asess whether administration of vitamin D makes any difference on the length of ICU stay

Phase 3

Completed

• Conditions: Health Condition 1: B999- Unspecified infectious disease

• Registration Number: CTRI/2019/12/022537
• Lead Sponsor: Dr amrita bhattacharyya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age between 18 to 80 years

2. Presenting to the emergency department and expected to be admitted to the ICU and survive for more than 96 hours.

3. Meet criteria for sepsis within past 12 hours

4. Enteral access in place to enable delivery of vitamin D or placebo and are deemed to be able to tolerate enteral drug administration

Exclusion Criteria

1. History of malabsorption syndromes or currently having gastrointestinal intolerance in the form of diarrhoea, vomiting or increased naso gastric aspirates.

2. Other trial participation,

3. Pregnant or lactating women;

4. Patients not deemed suitable for study participation (i.e., psychiatric disease, living remotely from the clinic, or prisoner status).

5. Age < 18 or >=80 years

6. Inability to obtain informed consent from patient/suitable proxy within 22 hours of new-onset severe sepsis

7. Comfort measures, hospice, or palliative care status

8. Documented adverse reaction to vitamin D supplementation

Renal stones within past year

Hypercalcemia within past year

Baseline serum calcium >=10.5 mg/dL

Established diagnosis of medical condition associated with high risk of hypercalcemia (e.g. metastatic cancer, sarcoidosis, multiple myeloma, primary hyperparathyroidism current hypercalcemia (albumin-corrected serum calcium > 10.8 mg/dL or ionized calcium > 5.2 mg/dL)

9. History of therapy with high dose vitamin D3 (greater than or equal to 50,000 IU a week) to treat vitamin D deficiency, within previous 6 months

10. Chronic dialysis;

11. >24 hours of sepsis diagnosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified