Vitamin D status in heart surgery patients and effects on clinical outcomes

In elective cardiac surgery patients, what is the effect of vitamin D status on clinical ICU outcomes, and does a 6 week period of vitamin D supplementation post surgery increase serum vitamin D levels in those found to be deficient?

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000516987

Acronym

Nil

Enrollment

100

Registered

2011-05-18

Start date

2011-07-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Vitamin D deficiency and insufficiency has been detected in the general community and is likely to be present in cardiac intensive care unit patients. This may impact recovery from surgery and rehospitalisation risk. The primary aim of this study is to identify the prevalence of vitamin D deficiency and insufficiency in cardiac ICU patients presenting to the Alfred Hospital. Secondary aims are to identify whether vitamin D deficiency or insufficiency is associated with longer ICU stay, longer ventilation time and/or APACHE 3 scores showing deterioration. And also to ascertain whether supplementation with 4000IU of vitamin D daily restores serum levels to within normal range.

Interventions

After initial screening before surgery, participants found to be deficient in vitamin D will be given oral supplements of 4000IU of vitamin D3 daily for 6 weeks after discharge from hospital.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All elective cardiac surgery patients over 18 years admitted to the Alfred hospital during the study period

Exclusion criteria

Patients unable to give informed consent; patients taking supplements containing vitamin D or who have taken them within the last 3 months; patients who have undergone parathyroidectomy; patients with hypercalcaemia or hyperphosphataemia; patients taking medications known to affect vitamin D metabolism; patients with liver failure or nephrotic syndrome

Outcome results