Vitamin D3 Supplementation in Dialysis Patients

Regional Hospital Holstebro

Status and phase: Completed; Phase 2

Conditions: End-Stage Renal Disease

Treatments: Drug: Placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01312714

EBP-TL-2011

Details and patient eligibility

About

Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemodialysis or peritoneal dialysis > 3 months

Exclusion criteria

• Hypercalceamia
• Cancer
• Inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Cholecalciferol

Active Comparator group

Treatment:

Drug: Cholecalciferol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo