Role of high dose vitamin D3 on anemia in mechanically ventilated patients with sepsis

Effect of high dose vitamin D3 on hemoglobin concentrations of mechanically ventilated patients with sepsis: A placebo-controlled randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042836

Enrollment

159

Registered

2022-05-26

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: A419- Sepsis, unspecified organism

Interventions

Intervention1: IV Vitamin D3: (600,000 IU) (Inj. ArachitolÃ¢â??Â¢ by Abbot Pharma) IM would be given on day 1 Intervention2: Oral Vitamin D3 sachet: (600,000 IU) (CalcitasÃ¢â??Â¢ by Intas Pharmaceuti

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are mechanically ventilated with invasive ventilation 2. Patients with sepsis (defined by new onset organ dysfunction with evidence of infection) 3. Age 18 years - 80 years 4. Patients expected to receive intensive care for > 48 hours

Exclusion criteria

Exclusion criteria: 1. Pregnancy and post-partum patients (till 42 days after delivery) 2. Disseminated malignancy, which is active 3. Patients already entered into any trial with intervention expected to have an effect on hemoglobin level 4. Admission to ICU within last 3 months 5. Patients having active bleeding from any source 6. Refractory shock 7. Patients having hypercalcemia (serum calcium > 10.5 mg/dl or ionized calcium levels > 5.4 mg/dl) 8. Morbid obesity (BMI > 40 kg/m2) 9. AIDS 10. Cirrhosis with varices 11. Chronic renal dysfunction requiring dialysis 12. Receipt of high-dose vitamin D3 therapy in the preceding 6 months 13. Patients not tolerating enteral feed 14. Hyperparathyroidism 15. History of allergy to Vitamin D3 or one of the excipients in the medications

Design outcomes

Primary

Measure	Time frame
1. The effect of high dose vitamin D3 would be gauged by the change in mean hemoglobin levels, between day 0 and day 14 2. difference in mean hemoglobin between the two groups at day 14 3. measuring the difference in serum hepcidin level between day 0 and day 14. 4. measuring the difference in serum erythropoietin level between day 0 and day 14. 5. difference in the median duration of hospital and ICU stay in the different groups 6.difference in the median days on ventilator in the different groups 7.difference in the average number of packed red cells requirement between the different groups by day 14. 8.measuring the difference in vitamin D, serum calcium, serum magnesium, serum PTH levels between day 0 and day 14. 9. measuring the difference in its level between day 0 and day 30 (after discharge) Timepoint: day 0 and day 14, day 30 after discharge	—

Measure

Time frame

1. The effect of high dose vitamin D3 would be gauged by the change in mean hemoglobin levels, between day 0 and day 14 2. difference in mean hemoglobin between the two groups at day 14 3. measuring the difference in serum hepcidin level between day 0 and day 14. 4. measuring the difference in serum erythropoietin level between day 0 and day 14. 5. difference in the median duration of hospital and ICU stay in the different groups 6.difference in the median days on ventilator in the different groups 7.difference in the average number of packed red cells requirement between the different groups by day 14. 8.measuring the difference in vitamin D, serum calcium, serum magnesium, serum PTH levels between day 0 and day 14. 9. measuring the difference in its level between day 0 and day 30 (after discharge) Timepoint: day 0 and day 14, day 30 after discharge

—

Secondary

Measure	Time frame
1. Disseminated malignancy, which is active 2. Patients already entered into any trial with intervention expected to have an effect on hemoglobin level 3. Admission to ICU within last 3 months 4. Patients having active bleeding from any source 5. Refractory shock 6. Patients having hypercalcemia (serum calcium 10.5 mg/dl or ionized calcium levels 5.4 mg/dl) 7. Morbid obesity (BMI 40 kg/m2) 8. AIDS 9. Cirrhosis with varices 10. Chronic renal dysfunction requiring dialysis 11. Receipt of high-dose vitamin D3 therapy in the preceding 6 months 12. Patients not tolerating enteral feed 13 Hyperparathyroidism 14. History of allergy to Vitamin D3 or one of the excipients in the medicationsTimepoint: day 0 and day 14, day 30 after discharge	—

Measure

Time frame

1. Disseminated malignancy, which is active 2. Patients already entered into any trial with intervention expected to have an effect on hemoglobin level 3. Admission to ICU within last 3 months 4. Patients having active bleeding from any source 5. Refractory shock 6. Patients having hypercalcemia (serum calcium 10.5 mg/dl or ionized calcium levels 5.4 mg/dl) 7. Morbid obesity (BMI 40 kg/m2) 8. AIDS 9. Cirrhosis with varices 10. Chronic renal dysfunction requiring dialysis 11. Receipt of high-dose vitamin D3 therapy in the preceding 6 months 12. Patients not tolerating enteral feed 13 Hyperparathyroidism 14. History of allergy to Vitamin D3 or one of the excipients in the medicationsTimepoint: day 0 and day 14, day 30 after discharge

—

Countries

India

Contacts

Public ContactAnimesh Ray

All India Institute of Medical Sciences

doctoranimeshray@gmail.com9560093190

Outcome results

None listed

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