DIVINE: Dialysis Infection and Vitamin D In New England

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Infection is the second-leading cause of death in individuals requiring dialysis treatment for kidney failure. New research suggests the high risk of infection may be due in part to low levels of vitamin D, which are extremely common in kidney disease. This study is designed to determine safe and effective ways to raise vitamin D levels while monitoring effects on the immune system.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion criteria

• Age ≥ 18 years

• Initiating chronic hemodialysis 3x/wk at Massachusetts General Hospital, Brigham and Women's Hospital or Beth Israel Deaconess Medical Center with planned transfer to Massachusetts chronic facility

• Serum 25D < 32 ng/ml

• Corrected serum calcium < 10.2 mg/dl

• Serum phosphate < 5.5 mg/dl

• Serum albumin > 3 g/dL

• Informed consent

Exclusion Criteria

• Pregnant or breastfeeding

• Women of childbearing potential not practicing one of the following measures of birth control: double-barrier method, hormonal contraceptives for at least 3 months prior to and during study, monogamous relationship with vasectomized partner, total abstinence from sexual intercourse with men during study.

• HIV positive

• History of allergic reaction to ergocalciferol

• Investigator considers subject unsuitable for any reason