Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency.

• Status: Terminated
• Trial end date: 2019-11-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the research study is to determine whether a single high dose of vitamin D is helpful in reducing critical illness related complications in intensive care patients who are having sever vitamin D deficiency.

Vitamin D deficiency is quite common in critically ill patients ranging from 81.5% to 99%. A number of scientific studies have documented a strong correlation between low levels of vit.D and increased rate of adverse outcomes including infection, acute kidney injury and mortality in ICU patients. A recent randomized controlled trial (RCT) has demonstrated a 50% reduction in hospital mortality in severe vit.D deficient patients following a single high dose of cholecalciferol (Vitamin D3). However, the role of Vit.D supplementation to boost up host immune system and eventually reduction of mortality has yet to be determined by large randomized controlled trials in humans. Hence the study aims to run a randomized controlled trial (RCT) in order to study the role of Vitamin D in critically ill patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Abdullah Medical City
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. 18 years or older.

2. Both male and female

3. Within 24 hours from admission.

4. Having 25 -Hydroxyvitamin D level of 12 ng/ml or lower.

Exclusion Criteria

1. Pregnant or lactating females.

2. Do not resuscitate (DNR) status or comfort measures only

3. No consent

4. Severely impaired gastrointestinal functions (e.g, paralytic ileus, continuous nasogastric tube drainage, strict nil per oral- no medication, malabsorption syndrome, chronic diarrhea etc)

5. History of renal stones within past year

6. Past history of hypercalcemia, tuberculosis or sarcoidosis.

7. Baseline serum total calcium ≥10.6 mg/dl or ionized serum calcium ≥ 5.4 mg/dl.