DIVINE: Dialysis Infection and Vitamin D In New England
Completed · Not applicable · Has a placebo group
Conditions studied: End Stage Renal Disease
In brief
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.
Key facts
- Study ID
- NCT00892099
- Run by
- Massachusetts General Hospital
- People needed
- 105
- Starts
- 2009-11-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2018-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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