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

Vitamin D (Vit D) administration has been shown to have beneficial effects on serum hemoglobin (Hb) level in patients with sepsis, however the optimum dose or route or degree of rise have not yet been evaluated. This single centre multiple arm open-label randomized placebo-controlled trial (RCT) was designed to determine the effect of high dose Vit D on Hb and other hematological parameters at 14 days/death (T1) and 14 days post-discharge (T2). The inclusion criteria of RCT was mechanically ventilated adult patients with sepsis who were expected to receive intensive care for > 48 hours. In the 3 arms, high dose Vit-D (600,000 IU) was given either by intramuscular (IM) /enteral route or a placebo (multivitamin, Vit D: 100 IU, enteral) was given on day 1; single dose. A total of 105 patients were recruited in the 3 arms. There were no baseline differences in terms of age, gender, underlying disease/comorbidities, inotrope requirement, hemoglobin, hepcidin, EPO, Vit D level, iron indices. Serum Vit D level was higher in the IM arm at T1 and T2, at T2 only in oral high dose arm, as compared to those receiving oral placebo. However, there was no difference in the measured Hb, serum hepcidin or erythropoetin, blood transfusion requirement, duration of ICU stay/ duration on ventilator and mortality. There were no serious adverse effects observed in any of the arms or differences in the minor side-effects between the three arms. High-dose vitamin D, via oral or intramuscular route, increases the serum Vit D level significantly in mechanically ventilated septic patients without any difference in the hemoglobin levels or serum markers.